Reported covered position: LD & Counsel, Congressman Joe Baca
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Income and expense are whole-filing amounts associated with this lobbyist, not personal compensation or an allocated share.
No topic inference: each bill number appears in source LDA issue text assigned to this lobbyist.
21st Century Cures Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. S. 2700 FDA and NIH Workforce Authorities Modernization Act, section 11 - provisions related to biological product innovation Implementation of Public Law 111-148 Biologics Price Competition and Innovation Act; all provisions. H.R. 34, The 21st Century Cures Act; all provisons
FDA and NIH Workforce Authorities Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Specific issues are shown only where the LDA source assigned them to this lobbyist. Targets apply to the associated filing.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2016 · fourth_quarter · Q4
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. S. 2700 FDA and NIH Workforce Authorities Modernization Act, section 11 - provisions related to biological product innovation Implementation of Public Law 111-148 Biologics Price Competition and Innovation Act; all provisions. H.R. 34, The 21st Century Cures Act; all provisons
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
Source: Senate LDA
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. S. 2700 FDA and NIH Workforce Authorities Modernization Act, section 11 - provisions related to biological product innovation Implementation of Public Law 111-148 Biologics Price Competition and Innovation Act; all provisions.
FDA and NIH Workforce Authorities Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. S. 2700 FDA and NIH Workforce Authorities Modernization Act, section 11 - provisions related to biological product innovation Implementation of Public Law 113-54 Drug Quality and Security Act; provisions related to regulating compounding. Implementation of Public Law 111-148 Biologics Price Competition and Innovation Act; all provisions.
FDA and NIH Workforce Authorities Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. S. 2700 FDA and NIH Workforce Authorities Modernization Act, section 11 - provisions related to biological product innovation Implementation of Public Law 111-148 Biologics Price Competition and Innovation Act; all provisions. H.R. 34, The 21st Century Cures Act; all provisons
Drug Quality and Security Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
Drug Quality and Security Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
Drug Quality and Security Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
Drug Quality and Security Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
Drug Quality and Security Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
Drug Quality and Security Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; provisions affecting categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act; all provisions - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards.
Pharmaceutical Quality, Security, and Accountability Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
Pharmaceutical Quality, Security, and Accountability Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
Pharmaceutical Quality, Security, and Accountability Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
Pharmaceutical Quality, Security, and Accountability Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
Pharmaceutical Quality, Security, and Accountability Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
Drug Safety Enhancement Act of 2011
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Comments to FDA on implementation of the Food Safety Modernization Act. - Letter to CMS regarding partnership for patients. - S. 1310, "Dietary Supplement Labeling Act of 2011", regarding all provisions. - H.R. 1483, "Drug Safety Enhancement Act of 2011", regarding Section 102 on drug supply quality and safety. - Comments to the FDA on streamlining and updating regulations.
Drug Safety Enhancement Act of 2011
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Implementation of the Food Safety Modernization Act. - Issues regarding creating and updating monographs. - Issues regarding FDA funding. - S 1584, "Drug Safety Accountability Act of 2011", regarding advice on drug quality. - HR 1483, "Drug Safety Enhancement Act of 2011", regarding advice on drug quality.
Drug Safety Enhancement Act of 2011
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - H.R. 1483, "Drug Safety Enhancement Act of 2011", regarding Section 102 on drug supply quality and safety. - H.R. 2227, "Medical Gas Safety Act", regarding Section 3, Regulation of Medical Gases. - H. 2112, "Agriculture Appropriations Bill, FY 2012", regarding support for FDA funding.
Medical Gas Safety Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - H.R. 1483, "Drug Safety Enhancement Act of 2011", regarding Section 102 on drug supply quality and safety. - H.R. 2227, "Medical Gas Safety Act", regarding Section 3, Regulation of Medical Gases. - H. 2112, "Agriculture Appropriations Bill, FY 2012", regarding support for FDA funding.
Drug Safety and Accountability Act of 2010
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - S. 3690, "Drug Quality and Safety Enhancement Act", regarding comments related to standards-setting for drugs and verification programs. - Comments on medication errors with respect to docket # FDA-2010-N-0168. - Communications in support of FDA funding.
American Middle Class Tax (AMT) Relief Act of 2007
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-H.R. 3590, "Patient Protection and Affordable Care Act"; provisions relating to follow on biologics and general issues of interest. -Advise on drug/food/dietary supplement/packaging standards-setting activities of USP. -Seek Congressional recognition of national standards. -Seek to educate/support Congress on USAID programs to advance quality drugs, and support USP verification programs.
American Middle Class Tax (AMT) Relief Act of 2007
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-Advise on drug/food/dietary supplement/packaging standards-setting activities of USP. -Seek Congressional recognition of national standards. -Seek to educate/support Congress on USAID programs to advance quality drugs, and support USP verification programs. -Drug quality legislation (pending), regarding compendial modernization/import safety. -FY 2011 FDA Appropriations, regarding provisions related to third-party certification and general support for mission. -H.R. 3590, "Patient Protection and Affordable Care Act"; provisions relating to follow on biologics and general issues of interest.
American Middle Class Tax (AMT) Relief Act of 2007
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-H.R. 3590, "Patient Protection and Affordable Care Act"; issues related to implementation and USP-related programs. - Advise on standards-setting, verification, overseas programs, and quality of medicines activiites related to drugs, dietary supplements, biologics and food ingredients.
To extend the temporary suspension of duty on certain nickel-metal hydride storage batteries designed for use in hybrid vehicles.
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- Advise on standards-setting, verification, overseas programs, and quality of medicines activiites related to drugs, dietary supplements, biologics and food ingredients. - HR 5116, "America Competes Act" (Reauthorization), regarding a recommendation to include work with nonprofit organizations in the list of NIST criteria for funding reference standards development. -Communications regarding the role and importance of standards; relation of USP standards to voluntary consensus standards. -Communications regarding the importance of strengthening USP's relationship with the FDA/Stakeholders to maintain up-to-date national standards. -Communications regarding updates on USP's USAID-funded activities, USP convention activities and resolutions.
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-GAO Study on Dietary Supplement Regulation, provided comments for. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization. -Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics. -Letter to Acting Commissioner of FDA regarding FDA budget and standards. -Communication with Congress on standards of use for heparin and glycerin. -Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources. -Provided information to Congress for a hearing on drug issues regarding intellectual property issues for drugs. -HR 1298 "Pharmaceutical Market Access & Drug Safety Act of 2009", regarding all provisions on the effect of re-importation provisions on FDA requirements and USP Compendial Standards for Drugs. -Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality. -HR 1427 / S 726 "Promoting Innovation and Access to Lifesaving Medicine Act", regarding all provisions on biologics; role and importance of standards, follow-on biologics. -HR 1548 "Pathway for Biosimilars Act", regarding all provisions on biologics; role of importance of standards, follow-on biologics. -HR 1105 "FY 2009 Omnibus Appropriations Act", regarding provisions on verification programs, standards and resources for FDA.
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -HR 1427/S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. -HR 1548, "Pathway for Biosimilars Act", regarding all provisions. -HR 1298/ S 525, "Pharmaceutical Market Access and Drug Safety Act of 2009", regarding all provisions in supporting the FDA and compendial standards for drugs (reimportation and importation). -Issues relating to Heparin, consultation on heparin and compendial standards. -S 882, "Drug and Device Accountability Act of 2009", regarding section 111 in support of compedial modernization. -S 369, "The Preserving Access to Affordable Generic Drugs Act", regarding all provisions. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission. -Communications with Congress regarding USP China MOU re: drugs.
Promoting Innovation and Access to Life-Saving Medicine Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-GAO Study on Dietary Supplement Regulation, provided comments for. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization. -Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics. -Letter to Acting Commissioner of FDA regarding FDA budget and standards. -Communication with Congress on standards of use for heparin and glycerin. -Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources. -Provided information to Congress for a hearing on drug issues regarding intellectual property issues for drugs. -HR 1298 "Pharmaceutical Market Access & Drug Safety Act of 2009", regarding all provisions on the effect of re-importation provisions on FDA requirements and USP Compendial Standards for Drugs. -Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality. -HR 1427 / S 726 "Promoting Innovation and Access to Lifesaving Medicine Act", regarding all provisions on biologics; role and importance of standards, follow-on biologics. -HR 1548 "Pathway for Biosimilars Act", regarding all provisions on biologics; role of importance of standards, follow-on biologics. -HR 1105 "FY 2009 Omnibus Appropriations Act", regarding provisions on verification programs, standards and resources for FDA.
Promoting Innovation and Access to Life-Saving Medicine Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -HR 1427/S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. -HR 1548, "Pathway for Biosimilars Act", regarding all provisions. -HR 1298/ S 525, "Pharmaceutical Market Access and Drug Safety Act of 2009", regarding all provisions in supporting the FDA and compendial standards for drugs (reimportation and importation). -Issues relating to Heparin, consultation on heparin and compendial standards. -S 882, "Drug and Device Accountability Act of 2009", regarding section 111 in support of compedial modernization. -S 369, "The Preserving Access to Affordable Generic Drugs Act", regarding all provisions. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission. -Communications with Congress regarding USP China MOU re: drugs.
Pathway for Biosimilars Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -HR 1427/S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. -HR 1548, "Pathway for Biosimilars Act", regarding all provisions. -HR 1298/ S 525, "Pharmaceutical Market Access and Drug Safety Act of 2009", regarding all provisions in supporting the FDA and compendial standards for drugs (reimportation and importation). -Issues relating to Heparin, consultation on heparin and compendial standards. -S 882, "Drug and Device Accountability Act of 2009", regarding section 111 in support of compedial modernization. -S 369, "The Preserving Access to Affordable Generic Drugs Act", regarding all provisions. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission. -Communications with Congress regarding USP China MOU re: drugs.
Pathway for Biosimilars Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-GAO Study on Dietary Supplement Regulation, provided comments for. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization. -Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics. -Letter to Acting Commissioner of FDA regarding FDA budget and standards. -Communication with Congress on standards of use for heparin and glycerin. -Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources. -Provided information to Congress for a hearing on drug issues regarding intellectual property issues for drugs. -HR 1298 "Pharmaceutical Market Access & Drug Safety Act of 2009", regarding all provisions on the effect of re-importation provisions on FDA requirements and USP Compendial Standards for Drugs. -Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality. -HR 1427 / S 726 "Promoting Innovation and Access to Lifesaving Medicine Act", regarding all provisions on biologics; role and importance of standards, follow-on biologics. -HR 1548 "Pathway for Biosimilars Act", regarding all provisions on biologics; role of importance of standards, follow-on biologics. -HR 1105 "FY 2009 Omnibus Appropriations Act", regarding provisions on verification programs, standards and resources for FDA.
Independent Drug Education and Outreach Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S 510 "FDA Food Safety Modernization Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 2749 "Food Safety Enhancement Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Independent Drug Education and Outreach Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- HR 1859, "Independent Drug Education & Outreach Act", regarding all provisions as a neutral, expert scientific resource. - S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. - Issues relating to heparin. - Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals, specifically to update Congress on USP standards. - Information on follow-on biologics. - Information on drug quality as a neutral, expert scientific resource.
Independent Drug Education and Outreach Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -HR 1427/S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. -HR 1548, "Pathway for Biosimilars Act", regarding all provisions. -HR 1298/ S 525, "Pharmaceutical Market Access and Drug Safety Act of 2009", regarding all provisions in supporting the FDA and compendial standards for drugs (reimportation and importation). -Issues relating to Heparin, consultation on heparin and compendial standards. -S 882, "Drug and Device Accountability Act of 2009", regarding section 111 in support of compedial modernization. -S 369, "The Preserving Access to Affordable Generic Drugs Act", regarding all provisions. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission. -Communications with Congress regarding USP China MOU re: drugs.
Comparative Effectiveness Research Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 574/ S 254, "Medicare Home Infusion Therapy Coverage Act of 2009", regarding section requesting USP to develop standards and formulary. -HR 684/ S 330, "Medicare Prescription Drug Savings and Choice Act of 2009", regarding sections cross referencing USP role with model guidelines under Part D. -HR 2502/ S 1213, "Comparative Effectiveness Research Act", regarding all provisions, specifically organizations eligible for grants related to comparative effectiveness research. -Healthcare reform bill regarding provisions relating to comparative effectiveness. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Food Safety Enhancement Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S 510 "FDA Food Safety Modernization Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 2749 "Food Safety Enhancement Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Food Safety Enhancement Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- S 510 "FDA Food Safety Modernization Act", regarding all provisions with specific reference to standards on ingredients and dietary supplements. - HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding all provisions with specific reference to standards on ingredients and dietary supplements. - HR 2749 "Food Safety Enhancement Act", regarding all provisions with specific reference to standards on ingredients and dietary supplements. - Communications on food quality.
Food Safety Enhancement Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S 510 "FDA Food Safety Modernization Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 2749 "Food Safety Enhancement Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -Agriculture Appropriations Bill regarding support funding for the Food and Drug Administration. -Issues regarding melamine and food ingredient standards. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
America's Affordable Health Choices Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- HR 3200, "America's Affordable health Choice Act of 2009", regarding the amendment on public option/ formularies, specifically, advise on USP's role with MMA Model Guidelines.
Medicare Home Infusion Therapy Coverage Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 574/ S 254, "Medicare Home Infusion Therapy Coverage Act of 2009", regarding section requesting USP to develop standards and formulary. -HR 684/ S 330, "Medicare Prescription Drug Savings and Choice Act of 2009", regarding sections cross referencing USP role with model guidelines under Part D. -HR 2502/ S 1213, "Comparative Effectiveness Research Act", regarding all provisions, specifically organizations eligible for grants related to comparative effectiveness research. -Healthcare reform bill regarding provisions relating to comparative effectiveness. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Medicare Home Infusion Therapy Coverage Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 574/ S 254, "Medicare Home Infusion Therapy Coverage Act of 2009", regarding section requesting USP to develop standards and formulary. -HR 684/ S 330, "Medicare Prescription Drug Savings and Choice Act of 2009", regarding sections cross referencing USP role with model guidelines under Part D. -Consultation on model guidelines, Medicare Modernization Act. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Medicare Prescription Drug Savings and Choice Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 574/ S 254, "Medicare Home Infusion Therapy Coverage Act of 2009", regarding section requesting USP to develop standards and formulary. -HR 684/ S 330, "Medicare Prescription Drug Savings and Choice Act of 2009", regarding sections cross referencing USP role with model guidelines under Part D. -HR 2502/ S 1213, "Comparative Effectiveness Research Act", regarding all provisions, specifically organizations eligible for grants related to comparative effectiveness research. -Healthcare reform bill regarding provisions relating to comparative effectiveness. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Medicare Prescription Drug Savings and Choice Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 574/ S 254, "Medicare Home Infusion Therapy Coverage Act of 2009", regarding section requesting USP to develop standards and formulary. -HR 684/ S 330, "Medicare Prescription Drug Savings and Choice Act of 2009", regarding sections cross referencing USP role with model guidelines under Part D. -Consultation on model guidelines, Medicare Modernization Act. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Food and Drug Administration Globalization Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- S 510 "FDA Food Safety Modernization Act", regarding all provisions with specific reference to standards on ingredients and dietary supplements. - HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding all provisions with specific reference to standards on ingredients and dietary supplements. - HR 2749 "Food Safety Enhancement Act", regarding all provisions with specific reference to standards on ingredients and dietary supplements. - Communications on food quality.
Food and Drug Administration Globalization Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-GAO Study on Dietary Supplement Regulation, provided comments for. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization. -Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics. -Letter to Acting Commissioner of FDA regarding FDA budget and standards. -Communication with Congress on standards of use for heparin and glycerin. -Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources. -Provided information to Congress for a hearing on drug issues regarding intellectual property issues for drugs. -HR 1298 "Pharmaceutical Market Access & Drug Safety Act of 2009", regarding all provisions on the effect of re-importation provisions on FDA requirements and USP Compendial Standards for Drugs. -Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality. -HR 1427 / S 726 "Promoting Innovation and Access to Lifesaving Medicine Act", regarding all provisions on biologics; role and importance of standards, follow-on biologics. -HR 1548 "Pathway for Biosimilars Act", regarding all provisions on biologics; role of importance of standards, follow-on biologics. -HR 1105 "FY 2009 Omnibus Appropriations Act", regarding provisions on verification programs, standards and resources for FDA.
Food and Drug Administration Globalization Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S 510 "FDA Food Safety Modernization Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 2749 "Food Safety Enhancement Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -Agriculture Appropriations Bill regarding support funding for the Food and Drug Administration. -Issues regarding melamine and food ingredient standards. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Food and Drug Administration Globalization Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-GAO Study on Dietary Supplement Regulation, provided comments for. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization. -Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics. -Letter to Acting Commissioner of the FDA regarding FDA budget and standards. -Communication with Congress on standards of use for heparin and glycerin. -Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to President Obama regarding food safety. -Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources. -Provided information to Congress for a hearing on drug issues with respect to intellectual property issues for drugs. -Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality.
Food and Drug Administration Globalization Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S 510 "FDA Food Safety Modernization Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 2749 "Food Safety Enhancement Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Food and Drug Administration Globalization Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- S 510 "FDA Food Safety Modernization Act", regarding all provisions, specifically advice to Congress on food ingredient standards in food safety legislation. - HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding all provisions, specifically advice to Congress on food ingredient standards in food safety legislation. -Advise on drug/food standards-setting activities of USP, including USP-NF, FCC, heparin, caps and ferrules.
Food and Drug Administration Globalization Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-GAO Study on Dietary Supplement Regulation, provided comments for. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization. -Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics. -Letter to Acting Commissioner of the FDA regarding FDA budget and standards. -Communication with Congress on standards of use for heparin and glycerin. -Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to President Obama regarding food safety. -Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality. -S 510 "FDA Food Safety Modernization Act", regarding all provisions with respect to food ingredient quality.
Patient-Centered Outcomes Research Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 574/ S 254, "Medicare Home Infusion Therapy Coverage Act of 2009", regarding section requesting USP to develop standards and formulary. -HR 684/ S 330, "Medicare Prescription Drug Savings and Choice Act of 2009", regarding sections cross referencing USP role with model guidelines under Part D. -HR 2502/ S 1213, "Comparative Effectiveness Research Act", regarding all provisions, specifically organizations eligible for grants related to comparative effectiveness research. -Healthcare reform bill regarding provisions relating to comparative effectiveness. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Medicare Home Infusion Therapy Coverage Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 574/ S 254, "Medicare Home Infusion Therapy Coverage Act of 2009", regarding section requesting USP to develop standards and formulary. -HR 684/ S 330, "Medicare Prescription Drug Savings and Choice Act of 2009", regarding sections cross referencing USP role with model guidelines under Part D. -HR 2502/ S 1213, "Comparative Effectiveness Research Act", regarding all provisions, specifically organizations eligible for grants related to comparative effectiveness research. -Healthcare reform bill regarding provisions relating to comparative effectiveness. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Medicare Home Infusion Therapy Coverage Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 574/ S 254, "Medicare Home Infusion Therapy Coverage Act of 2009", regarding section requesting USP to develop standards and formulary. -HR 684/ S 330, "Medicare Prescription Drug Savings and Choice Act of 2009", regarding sections cross referencing USP role with model guidelines under Part D. -Consultation on model guidelines, Medicare Modernization Act. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Physician Payments Sunshine Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- Issues relating to heparin. - S. 301, "Physician Payment Sunshine Act", regarding all provisions - Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals, specifically to update Congress on USP standards.
Medicare Prescription Drug Savings and Choice Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 574/ S 254, "Medicare Home Infusion Therapy Coverage Act of 2009", regarding section requesting USP to develop standards and formulary. -HR 684/ S 330, "Medicare Prescription Drug Savings and Choice Act of 2009", regarding sections cross referencing USP role with model guidelines under Part D. -Consultation on model guidelines, Medicare Modernization Act. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Medicare Prescription Drug Savings and Choice Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 574/ S 254, "Medicare Home Infusion Therapy Coverage Act of 2009", regarding section requesting USP to develop standards and formulary. -HR 684/ S 330, "Medicare Prescription Drug Savings and Choice Act of 2009", regarding sections cross referencing USP role with model guidelines under Part D. -HR 2502/ S 1213, "Comparative Effectiveness Research Act", regarding all provisions, specifically organizations eligible for grants related to comparative effectiveness research. -Healthcare reform bill regarding provisions relating to comparative effectiveness. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Preserve Access to Affordable Generics Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -HR 1427/S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. -HR 1548, "Pathway for Biosimilars Act", regarding all provisions. -HR 1298/ S 525, "Pharmaceutical Market Access and Drug Safety Act of 2009", regarding all provisions in supporting the FDA and compendial standards for drugs (reimportation and importation). -Issues relating to Heparin, consultation on heparin and compendial standards. -S 882, "Drug and Device Accountability Act of 2009", regarding section 111 in support of compedial modernization. -S 369, "The Preserving Access to Affordable Generic Drugs Act", regarding all provisions. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission. -Communications with Congress regarding USP China MOU re: drugs.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- S 510 "FDA Food Safety Modernization Act", regarding all provisions with specific reference to standards on ingredients and dietary supplements. - HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding all provisions with specific reference to standards on ingredients and dietary supplements. - HR 2749 "Food Safety Enhancement Act", regarding all provisions with specific reference to standards on ingredients and dietary supplements. - Communications on food quality.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-GAO Study on Dietary Supplement Regulation, provided comments for. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization. -Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics. -Letter to Acting Commissioner of the FDA regarding FDA budget and standards. -Communication with Congress on standards of use for heparin and glycerin. -Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to President Obama regarding food safety. -Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality. -S 510 "FDA Food Safety Modernization Act", regarding all provisions with respect to food ingredient quality.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- S 510 "FDA Food Safety Modernization Act", regarding all provisions, specifically advice to Congress on food ingredient standards in food safety legislation. - HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding all provisions, specifically advice to Congress on food ingredient standards in food safety legislation. -Advise on drug/food standards-setting activities of USP, including USP-NF, FCC, heparin, caps and ferrules.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S 510 "FDA Food Safety Modernization Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 2749 "Food Safety Enhancement Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S 510 "FDA Food Safety Modernization Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 2749 "Food Safety Enhancement Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -Agriculture Appropriations Bill regarding support funding for the Food and Drug Administration. -Issues regarding melamine and food ingredient standards. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Pharmaceutical Market Access and Drug Safety Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -HR 1427/S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. -HR 1548, "Pathway for Biosimilars Act", regarding all provisions. -HR 1298/ S 525, "Pharmaceutical Market Access and Drug Safety Act of 2009", regarding all provisions in supporting the FDA and compendial standards for drugs (reimportation and importation). -Issues relating to Heparin, consultation on heparin and compendial standards. -S 882, "Drug and Device Accountability Act of 2009", regarding section 111 in support of compedial modernization. -S 369, "The Preserving Access to Affordable Generic Drugs Act", regarding all provisions. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission. -Communications with Congress regarding USP China MOU re: drugs.
Promoting Innovation and Access to Life-Saving Medicine Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
- HR 1859, "Independent Drug Education & Outreach Act", regarding all provisions as a neutral, expert scientific resource. - S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. - Issues relating to heparin. - Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals, specifically to update Congress on USP standards. - Information on follow-on biologics. - Information on drug quality as a neutral, expert scientific resource.
Promoting Innovation and Access to Life-Saving Medicine Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-GAO Study on Dietary Supplement Regulation, provided comments for. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization. -Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics. -Letter to Acting Commissioner of FDA regarding FDA budget and standards. -Communication with Congress on standards of use for heparin and glycerin. -Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources. -Provided information to Congress for a hearing on drug issues regarding intellectual property issues for drugs. -HR 1298 "Pharmaceutical Market Access & Drug Safety Act of 2009", regarding all provisions on the effect of re-importation provisions on FDA requirements and USP Compendial Standards for Drugs. -Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality. -HR 1427 / S 726 "Promoting Innovation and Access to Lifesaving Medicine Act", regarding all provisions on biologics; role and importance of standards, follow-on biologics. -HR 1548 "Pathway for Biosimilars Act", regarding all provisions on biologics; role of importance of standards, follow-on biologics. -HR 1105 "FY 2009 Omnibus Appropriations Act", regarding provisions on verification programs, standards and resources for FDA.
Promoting Innovation and Access to Life-Saving Medicine Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -HR 1427/S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. -HR 1548, "Pathway for Biosimilars Act", regarding all provisions. -HR 1298/ S 525, "Pharmaceutical Market Access and Drug Safety Act of 2009", regarding all provisions in supporting the FDA and compendial standards for drugs (reimportation and importation). -Issues relating to Heparin, consultation on heparin and compendial standards. -S 882, "Drug and Device Accountability Act of 2009", regarding section 111 in support of compedial modernization. -S 369, "The Preserving Access to Affordable Generic Drugs Act", regarding all provisions. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission. -Communications with Congress regarding USP China MOU re: drugs.
Independent Drug Education and Outreach Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -HR 1427/S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. -HR 1548, "Pathway for Biosimilars Act", regarding all provisions. -HR 1298/ S 525, "Pharmaceutical Market Access and Drug Safety Act of 2009", regarding all provisions in supporting the FDA and compendial standards for drugs (reimportation and importation). -Issues relating to Heparin, consultation on heparin and compendial standards. -S 882, "Drug and Device Accountability Act of 2009", regarding section 111 in support of compedial modernization. -S 369, "The Preserving Access to Affordable Generic Drugs Act", regarding all provisions. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission. -Communications with Congress regarding USP China MOU re: drugs.
Independent Drug Education and Outreach Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S 510 "FDA Food Safety Modernization Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 2749 "Food Safety Enhancement Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Drug and Device Accountability Act of 2009
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -HR 1427/S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. -HR 1548, "Pathway for Biosimilars Act", regarding all provisions. -HR 1298/ S 525, "Pharmaceutical Market Access and Drug Safety Act of 2009", regarding all provisions in supporting the FDA and compendial standards for drugs (reimportation and importation). -Issues relating to Heparin, consultation on heparin and compendial standards. -S 882, "Drug and Device Accountability Act of 2009", regarding section 111 in support of compedial modernization. -S 369, "The Preserving Access to Affordable Generic Drugs Act", regarding all provisions. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission. -Communications with Congress regarding USP China MOU re: drugs.
American Middle Class Tax (AMT) Relief Act of 2007
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-H.R. 3590, "Patient Protection and Affordable Care Act"; provisions relating to insurance exchanges/formularies, specifically advise on USP role in Medicare Modernization Act Model Guidelines as they relate to healthcare. -H.R. 3962, "Affordable Healthcare for America Act", provisions relating to insurance exchanges/formularies, specifically advise on USP role in Medicare Modernization Act Model Guidelines as they relate to healthcare. - Academic detailing.
Superfund Polluter Pays Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-H.R. 3590, "Patient Protection and Affordable Care Act"; provisions relating to insurance exchanges/formularies, specifically advise on USP role in Medicare Modernization Act Model Guidelines as they relate to healthcare. -H.R. 3962, "Affordable Healthcare for America Act", provisions relating to insurance exchanges/formularies, specifically advise on USP role in Medicare Modernization Act Model Guidelines as they relate to healthcare. - Academic detailing.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-NO BILL NUMBER - Review revisions of FDA draft drug safety title, specific interest in the recognition of standards -S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-NO BILL NUMBER - Review revisions of FDA draft drug safety title, specific interest in the recognition of standards -S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-NO BILL NUMBER - Review revisions of FDA draft drug safety title, specific interest in the recognition of standards -S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions -S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-NO BILL NUMBER - Review revisions of FDA draft drug safety title, specific interest in the recognition of standards -S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions -S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
FDA Food Safety Modernization Act
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions -S. 3408: Comparative Effectiveness Research Act of 2008, Regarding all provisions -Review draft legislation on medication errors
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-NO BILL NUMBER - Review revisions to FDA draft drug safety title, specific interest in the recognition of standards -S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions -S. 3408: Comparative Effectiveness Research Act of 2008, Regarding all provisions -Review draft legislation on medication errors
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-NO BILL NUMBER - Review revisions of FDA draft drug safety title, specific interest in the recognition of standards -S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions -S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-NO BILL NUMBER - Review revisions of FDA draft drug safety title, specific interest in the recognition of standards -S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions -S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions -S. 3408: Comparative Effectiveness Research Act of 2008, Regarding all provisions -Review draft legislation on medication errors
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Independent Drug Education and Outreach Act of 2008
Client: THE UNITED STATES PHARMACOPEIAL CONVENTION · Firm: THE UNITED STATES PHARMACOPEIAL CONVENTION
-NO BILL NUMBER - Review revisions to FDA draft drug safety title, specific interest in the recognition of standards -S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions -S. 3408: Comparative Effectiveness Research Act of 2008, Regarding all provisions -Review draft legislation on medication errors
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2016 · third_quarter · Q3
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. S. 2700 FDA and NIH Workforce Authorities Modernization Act, section 11 - provisions related to biological product innovation Implementation of Public Law 111-148 Biologics Price Competition and Innovation Act; all provisions.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2016 · second_quarter · Q2
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. S. 2700 FDA and NIH Workforce Authorities Modernization Act, section 11 - provisions related to biological product innovation Implementation of Public Law 113-54 Drug Quality and Security Act; provisions related to regulating compounding. Implementation of Public Law 111-148 Biologics Price Competition and Innovation Act; all provisions.
Filing targets: Congressional Budget Office (CBO), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2016 · first_quarter · Q1
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
Filing targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE, U.S. Agency for International Development (USAID)
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2015 · fourth_quarter · Q4
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2015 · third_quarter · Q3
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. -Implementation of Public Law: 113-54; Drug Quality and Security Act; provisions related to compounding standards. -Implementation of Public Law 111-148; Biologic Price Competition and Innovation Act
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law No: 103-417; Dietary Supplement Health and Education Act of 1994
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2015 · second_quarter · Q2
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law No: 103-417; Dietary Supplement Health and Education Act of 1994
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. -Implementation of Public Law: 113-54.; Drug Quality and Security Act; provisions related to compounding standards.
Filing targets: Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2015 · first_quarter · Q1
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. -Implementation of Public Law: 113-54.; Drug Quality and Security Act; provisions related to compounding standards.
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. -Implementation of Public Law No: 112-144; Food Safety Modernization Act
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2014 · fourth_quarter · Q4
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. Implementation of Public Law: 113-54.; Drug Quality and Security Act; provisions related to compounding standards.
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. -Implementation of Public Law No: 112-144; Food Safety Modernization Act
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2014 · third_quarter · Q3
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. -Implementation of Public Law No: 112-144; Food Safety Modernization Act
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. Implementation of Public Law: 113-54.; Drug Quality and Security Act; provisions related to compounding standards.
Filing targets: HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2014 · second_quarter · Q2
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. -Implementation of Public Law No: 112-144; Food Safety Modernization Act
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. Implementation of Public Law: 113-54.; Drug Quality and Security Act; provisions related to compounding standards.
Filing targets: Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2014 · first_quarter · Q1
-Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; provisions affecting categories and classes - USP model guidelines and essential health benefits.
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. -Implementation of Public Law No: 112-144; Food Safety Modernization Act
Advise on standards-setting, verification, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act; all provisions -Implementation of Public Law: 113-54.; Drug Quality and Security Act; provisions related to compounding standards.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2013 · fourth_quarter · Q4
Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; provisions affecting categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act; all provisions - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards.
-Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; provisions affecting categories and classes - USP model guidelines and essential health benefits.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2013 · third_quarter · Q3
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2013 · second_quarter · Q2
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill;Additional issues include: compounding standards; essential health benefits; FDA funding; global health; drug shortages.
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill;Additional issues include: compounding standards; essential health benefits; FDA funding; global health; drug shortages.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2013 · first_quarter · Q1
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill; compounding standards; heavy metalsAdditional issues include: compounding standards; heavy metals; essential health benefits; FDA funding; global health; drug shortages.
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill; compounding standards; heavy metalsAdditional issues include: compounding standards; heavy metals; essential health benefits; FDA funding; global health; drug shortages.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2012 · fourth_quarter · Q4
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill; compounding standards; heavy metals
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill; compounding standards; heavy metals
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2012 · third_quarter · Q3
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2012 · second_quarter · Q2
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Implementation of Food Safety Modernization Act - Implementation of the FDA Fee Bill
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Implementation of Food Safety Modernization Act - Implementation of the FDA Fee Bill
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2012 · first_quarter · Q1
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Implementation of the Food Safety Modernization Act. - Issues regarding single-use vials. - Issues related to international and domestic standards-setting, verification, global strategy. - Issues related to FDA funding. - Issues related to supply chain.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Implementation of Food Safety Modernization Act
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2011 · fourth_quarter · Q4
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Implementation of the Food Safety Modernization Act. - Issues regarding FDA funding.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Implementation of the Food Safety Modernization Act. - Issues regarding creating and updating monographs. - Issues regarding FDA funding. - S 1584, "Drug Safety Accountability Act of 2011", regarding advice on drug quality. - HR 1483, "Drug Safety Enhancement Act of 2011", regarding advice on drug quality.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2011 · third_quarter · Q3
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Letters to the Food & Drug Administration regarding compendial standards and verification.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. .
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2011 · second_quarter · Q2
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - H.R. 1483, "Drug Safety Enhancement Act of 2011", regarding Section 102 on drug supply quality and safety. - H.R. 2227, "Medical Gas Safety Act", regarding Section 3, Regulation of Medical Gases. - H. 2112, "Agriculture Appropriations Bill, FY 2012", regarding support for FDA funding.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Letter to CMS regarding partnership for patients.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2011 · first_quarter · Q1
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Communications regarding the role of third party standards and USP programs. - Comments on FDA safe use initiative, particularly the role of USP programs.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2010 · fourth_quarter · Q4
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Inquiries relating to heparin and economically-motivated adulteration of drugs and food.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Inquiries relating to heparin and economically-motivated adulteration of drugs and food. - Comments on implementation of Biologics Price Competition and Innovation Act of 2009.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2010 · third_quarter · Q3
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Communications in support of FDA funding. - Communications regarding food and verification activities.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2010 · second_quarter · Q2
-H.R. 3590, "Patient Protection and Affordable Care Act"; issues related to implementation and USP-related programs. - Advise on standards-setting, verification, overseas programs, and quality of medicines activiites related to drugs, dietary supplements, biologics and food ingredients.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activiites related to drugs, dietary supplements, biologics and food ingredients.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activiites related to drugs, dietary supplements, biologics and food ingredients. - HR 5116, "America Competes Act" (Reauthorization), regarding a recommendation to include work with nonprofit organizations in the list of NIST criteria for funding reference standards development. -Communications regarding the role and importance of standards; relation of USP standards to voluntary consensus standards. -Communications regarding the importance of strengthening USP's relationship with the FDA/Stakeholders to maintain up-to-date national standards. -Communications regarding updates on USP's USAID-funded activities, USP convention activities and resolutions.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2010 · first_quarter · Q1
-H.R. 3590, "Patient Protection and Affordable Care Act"; provisions relating to follow on biologics and general issues of interest. -Advise on drug/food/dietary supplement/packaging standards-setting activities of USP. -Seek Congressional recognition of national standards. -Seek to educate/support Congress on USAID programs to advance quality drugs, and support USP verification programs.
-Advise on drug/food/dietary supplement/packaging standards-setting activities of USP. -Seek Congressional recognition of national standards. -Seek to educate/support Congress on USAID programs to advance quality drugs, and support USP verification programs. -FY 2011 FDA Appropriations, regarding provisions related to third-party certification and general support for mission.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2009 · fourth_quarter · Q4
-Advise on drug/food standards-setting activities of USP, including USP-NF, FCC, heparin, caps and ferrules. -Seek Congressional recognition of national standards. -Seek to educate/support Congress on USAID programs to advance quality drugs.
-Advise on drug/food standards-setting activities of USP, including USP-NF, FCC, heparin, caps and ferrules. -Seek Congressional recognition of national standards. -Seek to educate/support Congress on USAID programs to advance quality drugs.
- S 510 "FDA Food Safety Modernization Act", regarding all provisions, specifically advice to Congress on food ingredient standards in food safety legislation. - HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding all provisions, specifically advice to Congress on food ingredient standards in food safety legislation. -Advise on drug/food standards-setting activities of USP, including USP-NF, FCC, heparin, caps and ferrules.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2009 · third_quarter · Q3
- Issues relating to heparin. - S. 301, "Physician Payment Sunshine Act", regarding all provisions - Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals, specifically to update Congress on USP standards.
- HR 1859, "Independent Drug Education & Outreach Act", regarding all provisions as a neutral, expert scientific resource. - S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. - Issues relating to heparin. - Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals, specifically to update Congress on USP standards. - Information on follow-on biologics. - Information on drug quality as a neutral, expert scientific resource.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2009 · second_quarter · Q2
-HR 574/ S 254, "Medicare Home Infusion Therapy Coverage Act of 2009", regarding section requesting USP to develop standards and formulary. -HR 684/ S 330, "Medicare Prescription Drug Savings and Choice Act of 2009", regarding sections cross referencing USP role with model guidelines under Part D. -Consultation on model guidelines, Medicare Modernization Act. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
-HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -HR 1427/S 726, "Promoting Innovation and Access to Lifesaving Medicine Act, regarding all provisions. -HR 1548, "Pathway for Biosimilars Act", regarding all provisions. -HR 1298/ S 525, "Pharmaceutical Market Access and Drug Safety Act of 2009", regarding all provisions in supporting the FDA and compendial standards for drugs (reimportation and importation). -Issues relating to Heparin, consultation on heparin and compendial standards. -S 882, "Drug and Device Accountability Act of 2009", regarding section 111 in support of compedial modernization. -S 369, "The Preserving Access to Affordable Generic Drugs Act", regarding all provisions. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission. -Communications with Congress regarding USP China MOU re: drugs.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2009 · first_quarter · Q1
-GAO Study on Dietary Supplement Regulation, provided comments for. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization. -Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics. -Letter to Acting Commissioner of the FDA regarding FDA budget and standards. -Communication with Congress on standards of use for heparin and glycerin. -Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to President Obama regarding food safety. -Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality. -S 510 "FDA Food Safety Modernization Act", regarding all provisions with respect to food ingredient quality.
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2008 · fourth_quarter · Q4
-Briefing to GAO staff on a congressionally requested study on dietary supplement regulation.
-S. 3408: Comparative Effectiveness Research Act of 2008, Regarding all provisions - specifically standards setting organizations. -Review draft legislation on medication errors
-Briefing to GAO staff on a congressionally requested study on dietary supplement regulation. - S. 3408: Comparative Effectiveness Research Act of 2008, Regarding all provisions .
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2008 · third_quarter · 3A
-S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions
-S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions -S. 3408: Comparative Effectiveness Research Act of 2008, Regarding all provisions -Review draft legislation on medication errors
-NO BILL NUMBER - Review revisions to FDA draft drug safety title, specific interest in the recognition of standards -S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions -S. 3408: Comparative Effectiveness Research Act of 2008, Regarding all provisions -Review draft legislation on medication errors
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2008 · third_quarter · Q3
-S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions
-NO BILL NUMBER - Review revisions of FDA draft drug safety title, specific interest in the recognition of standards -S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions -S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions
-NO BILL NUMBER - Review revisions of FDA draft drug safety title, specific interest in the recognition of standards -S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions
THE UNITED STATES PHARMACOPEIAL CONVENTION via THE UNITED STATES PHARMACOPEIAL CONVENTION
2008 · third_quarter · RR
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. -Implementation of Public Law No: 112-144; Food Safety Modernization Act
Filing targets: Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
-Advise on standards-setting, verification, supply chain, overseas programs and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients.-Implementation of Public Law 112144; Food and Drug Administration Safety and Innovation Act of 2012; -Implementation of Public Law 111-148; Patient Protection and Affordable Care Act; categories and classes - USP model guidelines and essential health benefits. -Implementation of Public Law No: 112-144; Food Safety Modernization Act -Implementation of Public Law: 111-148; Biologic Price Competition and Innovation Act - HR 3204/and S. __; Drug Quality and Security Act; provisions related to compounding standards. -S. 959, Pharmaceutical Compounding Quality and Accountability Act
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS)
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill;Additional issues include: compounding standards; essential health benefits; FDA funding; global health; drug shortages.
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill;Additional issues include: compounding standards; essential health benefits; FDA funding; global health; drug shortages.
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee BillAdditional issues include: compounding standards; essential health benefits; FDA funding; global health; drug shortages.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS)
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee BillAdditional issues include: compounding standards; heavy metals; essential health benefits; FDA funding; global health; drug shortages.
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill; compounding standards; heavy metalsAdditional issues include: compounding standards; heavy metals; essential health benefits; FDA funding; global health; drug shortages.
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill; compounding standards; heavy metalsAdditional issues include: compounding standards; heavy metals; essential health benefits; FDA funding; global health; drug shortages.
Filing targets: Agriculture, Dept of (USDA), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, State, Dept of (DOS)
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill; compounding standards; heavy metals
Filing targets: Agriculture, Dept of (USDA), Centers For Disease Control & Prevention (CDC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
-Advise on standards-setting, verification, overseas programs, and quality of medicines -Activities related to drugs, dietary supplements, biologics and food ingredients. -Public Law No: 112-144 - Implementation of Food Safety Modernization Act -Implementation of the FDA Fee Bill
Filing targets: Centers For Disease Control & Prevention (CDC), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, State, Dept of (DOS)
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Implementation of Food Safety Modernization Act - Implementation of the FDA Fee Bill
Filing targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Implementation of the Food Safety Modernization Act. - Issues related to supply chain. - Issues related to international and domestic standards-setting, verification, global strategy.
Filing targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE, Treasury, Dept of, U.S. Trade Representative (USTR)
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Implementation of Food Safety Modernization Act
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Implementation of the Food Safety Modernization Act.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE, State, Dept of (DOS)
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
Filing targets: Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Comments to FDA on implementation of the Food Safety Modernization Act. - Letter to CMS regarding partnership for patients. - S. 1310, "Dietary Supplement Labeling Act of 2011", regarding all provisions. - H.R. 1483, "Drug Safety Enhancement Act of 2011", regarding Section 102 on drug supply quality and safety. - Comments to the FDA on streamlining and updating regulations.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Comments to FDA on implementation of the Food Safety Modernization Act. - S. 1310, "Dietary Supplement Labeling Act of 2011", regarding all provisions. - H. 2112, "Agriculture Appropriations Bill, FY 2012", regarding support for FDA funding. - Comments to the FDA on streamlining and updating regulations.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), SENATE
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - Communications regarding the role of third party standards and USP programs.
Filing targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Natl Institute of Standards & Technology (NIST), SENATE
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients.
Filing targets: Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE
- Advise on standards-setting, verification, overseas programs, and quality of medicines activities related to drugs, dietary supplements, biologics and food ingredients. - S. 3690, "Drug Quality and Safety Enhancement Act", regarding comments related to standards-setting for drugs and verification programs. - Comments on medication errors with respect to docket # FDA-2010-N-0168. - Communications in support of FDA funding.
Filing targets: Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), SENATE
- Advise on standards-setting, verification, overseas programs, and quality of medicines activiites related to drugs, dietary supplements, biologics and food ingredients. - Advocate exploring the development of quality standards of value to practitioners and the public; update on USP model guidelines; ideas for formulary activities.
- Advise on standards-setting, verification, overseas programs, and quality of medicines activiites related to drugs, dietary supplements, biologics and food ingredients. - Communications regarding the importance of continuing and expanding commitment to quality standard for food ingredients; Updates on global and verification activities. - Comments to the FDA on spices.
Filing targets: Agency for Healthcare Research & Quality (AHRQ), Centers For Disease Control & Prevention (CDC), Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institute of Standards & Technology (NIST), Natl Institutes of Health (NIH), SENATE, U.S. Agency for International Development (USAID)
-Advise on drug/food/dietary supplement/packaging standards-setting activities of USP. -Seek Congressional recognition of national standards. -Seek to educate/support Congress on USAID programs to advance quality drugs, and support USP verification programs. -Drug quality legislation (pending), regarding compendial modernization/import safety. -FY 2011 FDA Appropriations, regarding provisions related to third-party certification and general support for mission. -H.R. 3590, "Patient Protection and Affordable Care Act"; provisions relating to follow on biologics and general issues of interest.
-Advise on drug/food/dietary supplement/packaging standards-setting activities of USP. -Seek Congressional recognition of national standards. -Seek to educate/support Congress on USAID programs to advance quality drugs, and support USP verification programs. -Drug quality legislation (pending), regarding compendial modernization/import safety.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, U.S. Agency for International Development (USAID), Veterans Affairs, Dept of (VA)
-H.R. 3590, "Patient Protection and Affordable Care Act"; provisions relating to insurance exchanges/formularies, specifically advise on USP role in Medicare Modernization Act Model Guidelines as they relate to healthcare. -H.R. 3962, "Affordable Healthcare for America Act", provisions relating to insurance exchanges/formularies, specifically advise on USP role in Medicare Modernization Act Model Guidelines as they relate to healthcare. - Academic detailing.
Filing targets: Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Office of Management & Budget (OMB), SENATE, Veterans Affairs, Dept of (VA)
- Trade promotion.
- HR 3200, "America's Affordable health Choice Act of 2009", regarding the amendment on public option/ formularies, specifically, advise on USP's role with MMA Model Guidelines.
- S 510 "FDA Food Safety Modernization Act", regarding all provisions with specific reference to standards on ingredients and dietary supplements. - HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding all provisions with specific reference to standards on ingredients and dietary supplements. - HR 2749 "Food Safety Enhancement Act", regarding all provisions with specific reference to standards on ingredients and dietary supplements. - Communications on food quality.
Filing targets: Centers For Medicare and Medicaid Services (CMS), Commerce, Dept of (DOC), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Office of Management & Budget (OMB), SENATE
-S 510 "FDA Food Safety Modernization Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 2749 "Food Safety Enhancement Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 1859/ S 767, "Independent Drug Education & Outreach Act", regarding all provisions, specifically standards relating to academic detailing. -Consultation regarding exclusivity in drug law. -Information regarding USP General Chapter <1> Injections - labeling on ferrules and cap overseals. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
-S 510 "FDA Food Safety Modernization Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -HR 2749 "Food Safety Enhancement Act", regarding provisions on food ingredients with specific reference to standards, certification, verification, adulteration and contamination. -Agriculture Appropriations Bill regarding support funding for the Food and Drug Administration. -Issues regarding melamine and food ingredient standards. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
-HR 574/ S 254, "Medicare Home Infusion Therapy Coverage Act of 2009", regarding section requesting USP to develop standards and formulary. -HR 684/ S 330, "Medicare Prescription Drug Savings and Choice Act of 2009", regarding sections cross referencing USP role with model guidelines under Part D. -HR 2502/ S 1213, "Comparative Effectiveness Research Act", regarding all provisions, specifically organizations eligible for grants related to comparative effectiveness research. -Healthcare reform bill regarding provisions relating to comparative effectiveness. -Outreach to House and Senate staff to explain USP's standards setting mission. -Outreach to Administration to explain USP's standards setting mission.
Filing targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE
-GAO Study on Dietary Supplement Regulation, provided comments for. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization. -Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics. -Letter to Acting Commissioner of the FDA regarding FDA budget and standards. -Communication with Congress on standards of use for heparin and glycerin. -Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to President Obama regarding food safety. -Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources. -Provided information to Congress for a hearing on drug issues with respect to intellectual property issues for drugs. -Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality.
-HR 1 "The American Recovery and Reinvestment Act of 2009", regarding provisions related to healthcare research and quality and to NIST Appropriations.
-GAO Study on Dietary Supplement Regulation, provided comments for. -HR 759 "The Food and Drug Administration Globalization Act of 2009", regarding provisions on drugs and food ingredients with specific reference to drug quality, food quality and compendial modernization. -Letter to DHHS Secretary Designate regarding FDA Mission on drug quality, food quality, standards and follow-on biologics. -Letter to Acting Commissioner of FDA regarding FDA budget and standards. -Communication with Congress on standards of use for heparin and glycerin. -Communication with FDA regarding drug quality, food quality and follow-on biologics and FDA resources. -Letter to Congress on legislative issues before Congress regarding drug quality, food quality and follow-on biologics and FDA resources. -Provided information to Congress for a hearing on drug issues regarding intellectual property issues for drugs. -HR 1298 "Pharmaceutical Market Access & Drug Safety Act of 2009", regarding all provisions on the effect of re-importation provisions on FDA requirements and USP Compendial Standards for Drugs. -Letter to FDA Commissioner-Designate regarding FDA resources, drug quality and food quality. -HR 1427 / S 726 "Promoting Innovation and Access to Lifesaving Medicine Act", regarding all provisions on biologics; role and importance of standards, follow-on biologics. -HR 1548 "Pathway for Biosimilars Act", regarding all provisions on biologics; role of importance of standards, follow-on biologics. -HR 1105 "FY 2009 Omnibus Appropriations Act", regarding provisions on verification programs, standards and resources for FDA.
Response to the Congressional Budget Office on Medicare model guidelines in response to technical inquiry on formulation of guidelines.
Filing targets: Congressional Budget Office (CBO), Food & Drug Administration (FDA), Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), President of the U.S., SENATE
-S. 3408: Comparative Effectiveness Research Act of 2008, Regarding all provisions -Review draft legislation on medication errors -Response to staff on The United States Pharmacopeial Convention's standard on labeling for ferrules and cap overseals
Filing targets: Government Accountability Office (GAO), HOUSE OF REPRESENTATIVES, SENATE
-S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions
-NO BILL NUMBER - Review revisions of FDA draft drug safety title, specific interest in the recognition of standards -S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions -S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions
-NO BILL NUMBER - Review revisions of FDA draft drug safety title, specific interest in the recognition of standards -S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
-S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions -S. 3408: Comparative Effectiveness Research Act of 2008, Regarding all provisions -Review draft legislation on medication errors
-S. 3385: FDA Food Safety and Modernization Act, Regarding all provisions
-NO BILL NUMBER - Review revisions to FDA draft drug safety title, specific interest in the recognition of standards -S. 3396: Independent Drug Education Outreach Act of 2008, Regarding all provisions -S. 3408: Comparative Effectiveness Research Act of 2008, Regarding all provisions -Review draft legislation on medication errors
Filing targets: HOUSE OF REPRESENTATIVES, SENATE
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.
Issues relating to advancing public health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods. Revised FDA draft drug safety title; S 3385: FDA Food Safety Modernization Act, all provisions; S 3396: Independent Drug Education Outreach Act of 2008, all provisions; S 3408, Comparative Effectiveness Research Act of 2008, all provisions; Draft legislation on medication errors; FDA draft guidance for industry: Voluntary Third Party Certification.