STACEY RAMPY

FDA regulations and legislation affecting dietary supplements, medical foods and other natural products; regulations and legislation related to foods and dietary supplements containing CBD; Coronavirus impact and response; H.R.1629, Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023; H.R.1628, CBD Product Safety and Standardization Act of 2023.

FDA regulations and legislation affecting dietary supplements, medical foods and other natural products; regulations and legislation related to foods and dietary supplements containing CBD; Coronavirus impact and response; H.R.1629, Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023; H.R.1628, CBD Product Safety and Standardization Act of 2023.

FDA regulations and legislation affecting dietary supplements, medical foods and other natural products; regulations and legislation related to foods and dietary supplements containing CBD; Coronavirus impact and response; H.R.1629, Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023; H.R.1628, CBD Product Safety and Standardization Act of 2023.

FDA regulations and legislation affecting dietary supplements, medical foods and other natural products; regulations and legislation related to foods and dietary supplements containing CBD; Coronavirus impact and response; H.R.1629, Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023; H.R.1628, CBD Product Safety and Standardization Act of 2023.

FDA regulations and legislation affecting dietary supplements, medical foods and other natural products; regulations and legislation related to foods and dietary supplements containing CBD; Coronavirus impact and response; H.R.1629, Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023; H.R.1628, CBD Product Safety and Standardization Act of 2023.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; Medicare Part D redesign; and access to non-controlled medications. H.R.1350, Camerons Law. FY24 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations. H.R.1805, The Rare Disease Clinical Trials Pandemic Disruption Act. Reauthorization of the Pandemic and All-Hazards Preparedness Act. H.R.2673, The American Innovation and R&D Competitiveness Act.

Issues related to the development of therapies for rare diseases and sleep disorders; sleep health equity; drug pricing; and access to non-controlled medications. H.R.1350, Camerons Law. FY24 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations. H.R.1805, Leos Law. Issues related to the implementation of Inflation Reduction Act Medicare Part D redesign policy. H.R.830, S.1375, The HELP Copays Act. H.R.5539, The ORPHAN Cures Act.

Issues related to the development of therapies for rare diseases and sleep disorders; sleep health equity; drug pricing; and access to non-controlled medications. H.R.1350, Camerons Law. FY24 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations. H.R.1805, Leos Law. Reauthorization of the Pandemic and All-Hazards Preparedness Act. Issues related to the implementation of Inflation Reduction Act Medicare Part D redesign policy. H.R.830, S.1375, The HELP Copays Act.

Issues impacting diagnostics including FDA regulation of laboratory developed tests; H.R.2369, VALID Act of 2023.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement for clinical laboratory services. FDA regulation of clinical laboratory services. Coronavirus impact and response. H.R.2377/S.1000, Saving Access to Laboratory Services Act. Reauthorization of the Pandemic and All-Hazards Preparedness Act. H.R.3791, Improving DATA in Public Health Act. H.R.3248, Diagnostic Lab Testing Transparency Act. FY 2024 budget and appropriations process.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement for clinical laboratory services. FDA regulation of clinical laboratory services. Coronavirus impact and response. H.R.2377/S.1000, Saving Access to Laboratory Services Act. H.R.3791, Improving DATA in Public Health Act. H.R.3248, Diagnostic Lab Testing Transparency Act. FY 2024 budget and appropriations process. Reauthorization of the Pandemic and All-Hazards Preparedness Act, S.2333, Pandemic and All-Hazards Preparedness and Response Act, H.R.4420, Preparedness and Response Reauthorization Act, H.R.4421, Preparing for All Hazards and Pathogens Reauthorization Act.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, animal research, childhood nutrition, vaccines and immunizations; Coronavirus impact and response; Advanced Research Project Agency-Health issues; H.R.2389/S.1302, Resident Physician Shortage Reduction Act of 2023.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, animal research, childhood nutrition, vaccines and immunizations; Coronavirus impact and response; Advanced Research Project Agency-Health issues; H.R.2389/S.1302, Resident Physician Shortage Reduction Act of 2023.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, animal research, childhood nutrition, vaccines and immunizations; policies impacting Medicare coverage and reimbursement for clinical laboratory services; Coronavirus impact and response; Advanced Research Project Agency-Health issues; H.R.2389, Resident Physician Shortage Reduction Act of 2023.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; Medicare Part D redesign; and access to non-controlled medications. H.R.1350, Camerons Law. FY24 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations. H.R.1805, The Rare Disease Clinical Trials Pandemic Disruption Act. Reauthorization of the Pandemic and All-Hazards Preparedness Act. H.R.2673, The American Innovation and R&D Competitiveness Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement for clinical laboratory services. FDA regulation of clinical laboratory services. Coronavirus impact and response. H.R.2377/S.1000, Saving Access to Laboratory Services Act. H.R.3791, Improving DATA in Public Health Act. H.R.3248, Diagnostic Lab Testing Transparency Act. FY 2024 budget and appropriations process. Reauthorization of the Pandemic and All-Hazards Preparedness Act, S.2333, Pandemic and All-Hazards Preparedness and Response Act, H.R.4420, Preparedness and Response Reauthorization Act, H.R.4421, Preparing for All Hazards and Pathogens Reauthorization Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement for clinical laboratory services. FDA regulation of clinical laboratory services. Coronavirus impact and response. H.R.2377/S.1000, Saving Access to Laboratory Services Act. Reauthorization of the Pandemic and All-Hazards Preparedness Act. H.R.3791, Improving DATA in Public Health Act. H.R.3248, Diagnostic Lab Testing Transparency Act. FY 2024 budget and appropriations process.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement for clinical laboratory services. FDA regulation of clinical laboratory services. Coronavirus impact and response. H.R.2377/S.1000, Saving Access to Laboratory Services Act. Reauthorization of the Pandemic and All-Hazards Preparedness Act. H.R.3791, Improving DATA in Public Health Act. H.R.3248, Diagnostic Lab Testing Transparency Act. FY 2024 budget and appropriations process.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement for clinical laboratory services. FDA regulation of clinical laboratory services. Coronavirus impact and response. H.R.2377/S.1000, Saving Access to Laboratory Services Act. H.R.3791, Improving DATA in Public Health Act. H.R.3248, Diagnostic Lab Testing Transparency Act. FY 2024 budget and appropriations process. Reauthorization of the Pandemic and All-Hazards Preparedness Act, S.2333, Pandemic and All-Hazards Preparedness and Response Act, H.R.4420, Preparedness and Response Reauthorization Act, H.R.4421, Preparing for All Hazards and Pathogens Reauthorization Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement for clinical laboratory services. FDA regulation of clinical laboratory services. Coronavirus impact and response. H.R.2377/S.1000, Saving Access to Laboratory Services Act. H.R.3791, Improving DATA in Public Health Act. H.R.3248, Diagnostic Lab Testing Transparency Act. FY 2024 budget and appropriations process. Reauthorization of the Pandemic and All-Hazards Preparedness Act, S.2333, Pandemic and All-Hazards Preparedness and Response Act, H.R.4420, Preparedness and Response Reauthorization Act, H.R.4421, Preparing for All Hazards and Pathogens Reauthorization Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement for clinical laboratory services. FDA regulation of clinical laboratory services. Coronavirus impact and response. H.R.2377/S.1000, Saving Access to Laboratory Services Act. H.R.3791, Improving DATA in Public Health Act. H.R.3248, Diagnostic Lab Testing Transparency Act. FY 2024 budget and appropriations process. Reauthorization of the Pandemic and All-Hazards Preparedness Act, S.2333, Pandemic and All-Hazards Preparedness and Response Act, H.R.4420, Preparedness and Response Reauthorization Act, H.R.4421, Preparing for All Hazards and Pathogens Reauthorization Act.

Issues related to the development of therapies for rare diseases and sleep disorders; sleep health equity; drug pricing; and access to non-controlled medications. H.R.1350, Camerons Law. FY24 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations. H.R.1805, Leos Law. Issues related to the implementation of Inflation Reduction Act Medicare Part D redesign policy. H.R.830, S.1375, The HELP Copays Act. H.R.5539, The ORPHAN Cures Act.

Issues related to the development of therapies for rare diseases and sleep disorders; sleep health equity; drug pricing; and access to non-controlled medications. H.R.1350, Camerons Law. FY24 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations. H.R.1805, Leos Law. Reauthorization of the Pandemic and All-Hazards Preparedness Act. Issues related to the implementation of Inflation Reduction Act Medicare Part D redesign policy. H.R.830, S.1375, The HELP Copays Act.

Issues related to the development of therapies for rare diseases and sleep disorders; sleep health equity; drug pricing; and access to non-controlled medications. H.R.1350, Camerons Law. FY24 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations. H.R.1805, Leos Law. Issues related to the implementation of Inflation Reduction Act Medicare Part D redesign policy. H.R.830, S.1375, The HELP Copays Act. H.R.5539, The ORPHAN Cures Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement for clinical laboratory services. FDA regulation of clinical laboratory services. Coronavirus impact and response. H.R.2377/S.1000, Saving Access to Laboratory Services Act. Reauthorization of the Pandemic and All-Hazards Preparedness Act. H.R.3791, Improving DATA in Public Health Act. H.R.3248, Diagnostic Lab Testing Transparency Act. FY 2024 budget and appropriations process.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement for clinical laboratory services. FDA regulation of clinical laboratory services. Coronavirus impact and response. H.R.2377/S.1000, Saving Access to Laboratory Services Act. H.R.3791, Improving DATA in Public Health Act. H.R.3248, Diagnostic Lab Testing Transparency Act. FY 2024 budget and appropriations process. Reauthorization of the Pandemic and All-Hazards Preparedness Act, S.2333, Pandemic and All-Hazards Preparedness and Response Act, H.R.4420, Preparedness and Response Reauthorization Act, H.R.4421, Preparing for All Hazards and Pathogens Reauthorization Act.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, animal research, childhood nutrition, vaccines and immunizations; Coronavirus impact and response; Advanced Research Project Agency-Health issues; H.R.2389/S.1302, Resident Physician Shortage Reduction Act of 2023.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, animal research, childhood nutrition, vaccines and immunizations; Coronavirus impact and response; Advanced Research Project Agency-Health issues; H.R.2389/S.1302, Resident Physician Shortage Reduction Act of 2023.

Issues related to the development of therapies for rare diseases and sleep disorders; sleep health equity; drug pricing; and access to non-controlled medications. H.R.1350, Camerons Law. FY24 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations. H.R.1805, Leos Law. Reauthorization of the Pandemic and All-Hazards Preparedness Act. Issues related to the implementation of Inflation Reduction Act Medicare Part D redesign policy. H.R.830, S.1375, The HELP Copays Act.

Issues related to the development of therapies for rare diseases and sleep disorders; sleep health equity; drug pricing; and access to non-controlled medications. H.R.1350, Camerons Law. FY24 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations. H.R.1805, Leos Law. Issues related to the implementation of Inflation Reduction Act Medicare Part D redesign policy. H.R.830, S.1375, The HELP Copays Act. H.R.5539, The ORPHAN Cures Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement for clinical laboratory services. FDA regulation of clinical laboratory services. Coronavirus impact and response. H.R.2377/S.1000, Saving Access to Laboratory Services Act. H.R.3791, Improving DATA in Public Health Act. H.R.3248, Diagnostic Lab Testing Transparency Act. FY 2024 budget and appropriations process. Reauthorization of the Pandemic and All-Hazards Preparedness Act, S.2333, Pandemic and All-Hazards Preparedness and Response Act, H.R.4420, Preparedness and Response Reauthorization Act, H.R.4421, Preparing for All Hazards and Pathogens Reauthorization Act.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R.1730/S.670, The Speeding Therapy Access Today (STAT) Act of 2021.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R.1730/S.670, The Speeding Therapy Access Today (STAT) Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, animal research, childhood nutrition, vaccines and immunizations; policies impacting Medicare coverage and reimbursement for clinical laboratory services; Coronavirus impact and response; Implementation of H.R.748, CARES Act (P.L.116-136); S.834/H.R.2256, Resident Physician Shortage Reduction Act of 2021.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, animal research, childhood nutrition, vaccines and immunizations; policies impacting Medicare coverage and reimbursement for clinical laboratory services; Coronavirus impact and response; Advanced Research Project Agency-Health issues; S.834/H.R.2256, Resident Physician Shortage Reduction Act of 2021.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, animal research, childhood nutrition, vaccines and immunizations; policies impacting Medicare coverage and reimbursement for clinical laboratory services; Coronavirus impact and response; Advanced Research Project Agency-Health issues; S.834/H.R.2256, Resident Physician Shortage Reduction Act of 2021.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, animal research, childhood nutrition, vaccines and immunizations; policies impacting Medicare coverage and reimbursement for clinical laboratory services; Coronavirus impact and response; S.834/H.R.2256, Resident Physician Shortage Reduction Act of 2021.

FDA regulations and legislation affecting dietary supplements, medical foods and other natural products; regulations and legislation related to foods and dietary supplements containing CBD; Coronavirus impact and response; Implementation of H.R.748, CARES Act (P.L.116-136); H.R.841, Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021; FY2022 Consolidated Appropriations Act (H.R.2471, P.L.117-103); FY2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services); Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); Implementation of H.R.748, CARES Act (P.L.116-136); MDUFA Reauthorization; S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); FY2022 Consolidated Appropriations Act (H.R.2471, P.L.117-103); Y2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; S.3799, PREVENT Pandemics Act.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, childhood nutrition, kidney research and development, and long COVID syndrome; FY2022 Consolidated Appropriations Act (H.R.2471, P.L.117-103); FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; FY2022 Budget Reconciliation (H.R.5376).

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, childhood nutrition, kidney research and development, and long COVID syndrome; FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.8295, S.4659); FY2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (H.R.8239, S.4661); H.R.2617, Consolidated Appropriations Act, 2023.

Issues related to infant formula and medical nutrition; S.4348, FDASLA Act of 2022; H.R.2617, Consolidated Appropriations Act, 2023.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services), H.R.8188, To amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes; Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); H.R.8188/S.4449, Saving Access to Laboratory Services Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.8295, S.4659); S.3799, PREVENT Pandemics Act; H.R.8152, American Data Privacy and Protection Act; H.R.6202, Telehealth Extension Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.6000, Cures 2.0 Act; H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.7559, Prescription Information Modernization Act of 2022; H.R.2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.

Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.2617, Consolidated Appropriations Act, 2023.

FDA regulations and legislation affecting dietary supplements, medical foods and other natural products; regulations and legislation related to foods and dietary supplements containing CBD; Coronavirus impact and response; H.R.841, Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021; FY2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (H.R.8239, S.4661); S.4090, Dietary Supplement Listing Act of 2022; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.2617, Consolidated Appropriations Act, 2023.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R.1730/S.670, The Speeding Therapy Access Today (STAT) Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R.1730/S.670, The Speeding Therapy Access Today (STAT) Act of 2021.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R.1730/S.670, The Speeding Therapy Access Today (STAT) Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.6000, Cures 2.0 Act; H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.7559, Prescription Information Modernization Act of 2022; H.R.2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.7559, Prescription Information Modernization Act of 2022; H.R.2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act.

Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022.

Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; Implementation of H.R.748, CARES Act (P.L.116-136); H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; PDUFA Reauthorization; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; PDUFA Reauthorization; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services), H.R.8188, To amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes, S.4449, Saving Access to Laboratory Services Act; Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); H.R.7667, Food and Drug Amendments of 2022, S.4348, FDASLA Act of 2022, H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.8295, S.4659); S.3799, PREVENT Pandemics Act; H.R.8152, American Data Privacy and Protection Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services), H.R.8188, To amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes, S.4449, Saving Access to Laboratory Services Act; Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); MDUFA Reauthorization, H.R.7667, Food and Drug Amendments of 2022, S.4348, FDASLA Act of 2022; S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.8295, Senate); S.3799, PREVENT Pandemics Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services); Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); Implementation of H.R.748, CARES Act (P.L.116-136); MDUFA Reauthorization; S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); FY2022 Consolidated Appropriations Act (H.R.2471, P.L.117-103); Y2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; S.3799, PREVENT Pandemics Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services), H.R.8188, To amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes; Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); H.R.8188/S.4449, Saving Access to Laboratory Services Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.8295, S.4659); S.3799, PREVENT Pandemics Act; H.R.8152, American Data Privacy and Protection Act; H.R.6202, Telehealth Extension Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services), H.R.8188, To amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes; Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); H.R.8188/S.4449, Saving Access to Laboratory Services Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.8295, S.4659); S.3799, PREVENT Pandemics Act; H.R.8152, American Data Privacy and Protection Act; H.R.6202, Telehealth Extension Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services), H.R.8188, To amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes, S.4449, Saving Access to Laboratory Services Act; Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); H.R.7667, Food and Drug Amendments of 2022, S.4348, FDASLA Act of 2022, H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.8295, S.4659); S.3799, PREVENT Pandemics Act; H.R.8152, American Data Privacy and Protection Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services); Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); Implementation of H.R.748, CARES Act (P.L.116-136); MDUFA Reauthorization; S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); FY2022 Consolidated Appropriations Act (H.R.2471, P.L.117-103); Y2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; S.3799, PREVENT Pandemics Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services), H.R.8188, To amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes, S.4449, Saving Access to Laboratory Services Act; Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); MDUFA Reauthorization, H.R.7667, Food and Drug Amendments of 2022, S.4348, FDASLA Act of 2022; S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.8295, Senate); S.3799, PREVENT Pandemics Act.

Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022.

Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180).

Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.2617, Consolidated Appropriations Act, 2023.

Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; Implementation of H.R.748, CARES Act (P.L.116-136); H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.6000, Cures 2.0 Act; H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.7559, Prescription Information Modernization Act of 2022; H.R.2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.7559, Prescription Information Modernization Act of 2022; H.R.2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, childhood nutrition, kidney research and development, and long COVID syndrome; FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.8295, S.4659); FY2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (H.R.8239, S.4661); FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169).

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; PDUFA Reauthorization; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, childhood nutrition, kidney research and development, and long COVID syndrome; FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.8295, Senate); FY2023 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act (H.R.8239, Senate); FY2022 Budget Reconciliation (H.R.5376).

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services); Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); Implementation of H.R.748, CARES Act (P.L.116-136); MDUFA Reauthorization; S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); FY2022 Consolidated Appropriations Act (H.R.2471, P.L.117-103); Y2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; S.3799, PREVENT Pandemics Act.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services), H.R.8188, To amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes, S.4449, Saving Access to Laboratory Services Act; Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); H.R.7667, Food and Drug Amendments of 2022, S.4348, FDASLA Act of 2022, H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.8295, S.4659); S.3799, PREVENT Pandemics Act; H.R.8152, American Data Privacy and Protection Act.

Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; PDUFA Reauthorization; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022.

Issues related to neglected tropical diseases, space biomedical research, medical schools, health research, childhood nutrition, kidney research and development, and long COVID syndrome; FY2022 Consolidated Appropriations Act (H.R.2471, P.L.117-103); FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations; FY2022 Budget Reconciliation (H.R.5376).

Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180).

Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; Implementation of H.R.748, CARES Act (P.L.116-136); H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act.

Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services), H.R.8188, To amend title XVIII of the Social Security Act to improve the accuracy of market-based Medicare payment for clinical diagnostic laboratory services, to reduce administrative burdens in the collection of data, and for other purposes, S.4449, Saving Access to Laboratory Services Act; Policies impacting Medicare coverage and reimbursement for clinical laboratory services; FDA regulation of clinical laboratory services; Coronavirus impact and response; Implementation of H.R.3584/S.3049, Laboratory Access for Beneficiaries Act (P.L.116-94); MDUFA Reauthorization, H.R.7667, Food and Drug Amendments of 2022, S.4348, FDASLA Act of 2022; S.2209/H.R.4128, Verifying Accurate Leading-edge IVCT Development Act 6 of 2021; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); FY2023 Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Act (H.R.8295, Senate); S.3799, PREVENT Pandemics Act.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R.1730/S.670, The Speeding Therapy Access Today (STAT) Act of 2021.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.7559, Prescription Information Modernization Act of 2022; H.R.2873, Affordable Prescriptions for Patients Through Promoting Competition Act of 2021.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation/Inflation Reduction Act of 2022 (H.R.5376, P.L.117-169); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.6833, Making continuing appropriations for fiscal year 2023, and for other purposes (P.L.117-180); H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R.1730/S.670, The Speeding Therapy Access Today (STAT) Act of 2021.

Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; PDUFA Reauthorization; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022.

Legislation and regulations affecting medical devices, pharmaceuticals, cosmetics and other consumer products; Coronavirus impact and response; social determinants of health; policies impacting Medicare coverage and reimbursement for prescription drugs; MDUFA Reauthorization; PDUFA Reauthorization; Implementation of H.R.748, CARES Act (P.L.116-136); H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; H.R.5030/S.2706, DIVERSE Trials Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; S.3799, PREVENT Pandemics Act.

Provide legislative and regulatory advice related to vaccine development, drug pricing, the 340B Drug Pricing Program, PDUFA Reauthorization, and clinical trial diversity; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.5030/S.2706, DIVERSE Trials Act; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; access to non-controlled medications; PDUFA Reauthorization; H.R.6000, Cures 2.0 Act; H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.2623, Camerons Law; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022; H.R.8641, Orphan Drug COVID-19 Mitigation Act of 2022; H.R.1730/S.670, The Speeding Therapy Access Today (STAT) Act of 2021; H.R.2617, Consolidated Appropriations Act, 2023.

Issues related to the development of therapies for rare diseases and sleep disorders; drug pricing; PDUFA Reauthorization; H.R.3, Elijah E. Cummings Lower Drug Costs Now Act; H.R.6000, Cures 2.0 Act; FY2022 Budget Reconciliation (H.R.5376); H.R.5585, Advanced Research Project Agency-Health Act; H.R.6963, Accelerated Approval Integrity Act of 2022; H.R.7667, Food and Drug Amendments of 2022; S.4348, FDASLA Act of 2022.