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Drug Shortages Shelf Life Extension Act
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vs 9,698 other HR bills in the 117th — cohort avg 63d
Drug Shortages Shelf Life Extension Act This bill requires the Food and Drug Administration (FDA) to issue or revise guidance to address issues relating to extending drug expiration dates. Specifically, the guidance must address recommendations to drug companies relating to (1) submitting stability testing data in applications for market approval for drugs or biological products; (2) establishing on drug labels the longest feasible expiration date scientifically supported by such data, taking into consideration how extended expiration dates may help prevent or mitigate drug shortages and affect product quality; and (3) using innovative approaches to stability modeling to support initial product expiration dates and expiration date extensions. The FDA must also periodically report to Congress certain information about requests to change the expiration date on a drug label, including the number of such requests from the FDA to the manufacturer and the rationale for each request.
These links require the bill number to appear in the filing's source-reported specific issue text. Client expenses and lobbying-firm income are separate disclosure fields.
Filing registrants (1)
2022 · fourth_quarter · Food Industry (safety, labeling, etc.)
The Child Nutrition Reauthorization Act Precautionary Allergen Labels Labeling Medicine S. 3493, H.R. 7669, Drug Shortages Shelf Life Extension Act Appropriations requests for increased federal research and safer schools The FASTER Act, S. 578
Client expense: $35,000 · Firm income: Not reported
Referred to the House Committee on Energy and Commerce.
Introduced in House
Congress.gov source codes: 1000, Intro-H
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Sources: Congress.gov
Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2022 · third_quarter · Food Industry (safety, labeling, etc.)
The Child Nutrition Reauthorization Act Precautionary Allergen Labels Labeling Medicine S. 3493, H.R. 7669, Drug Shortages Shelf Life Extension Act Appropriations requests for increased federal research and safer schools
Client expense: $35,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE
2022 · third_quarter · Food Industry (safety, labeling, etc.)
The Child Nutrition Reauthorization Act Precautionary Allergen Labels Labeling Medicine S. 3493, H.R. 7669, Drug Shortages Shelf Life Extension Act Appropriations requests for increased federal research and safer schools The White House Conference on Nutrition and Hunger
Client expense: $20,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE, White House Office
2022 · second_quarter · Food Industry (safety, labeling, etc.)
The Child Nutrition Reauthorization Act Precautionary Allergen Labels Labeling Medicine S. 3493, H.R. 7669, Drug Shortages Shelf Life Extension Act Appropriations requests for increased federal research and safer schools
Client expense: $35,000 · Firm income: Not reported
Government targets: Agriculture, Dept of (USDA), Food & Drug Administration (FDA), HOUSE OF REPRESENTATIVES, Health & Human Services, Dept of (HHS), Natl Institutes of Health (NIH), SENATE