summary
Introduced
04/26/2021
04/26/2021
In Committee
04/27/2021
04/27/2021
Crossed Over
Passed
Dead
01/03/2023
01/03/2023
Introduced Session
117th Congress
Bill Summary
A BILL To amend the Federal Food, Drug, and Cosmetic Act to provide for the prompt approval of drugs when safety information is added to labeling, and for other purposes.
AI Summary
This bill, the Prompt Approval of Safe Generic Drugs Act, amends the Federal Food, Drug, and Cosmetic Act to allow for the prompt approval of generic drug applications that omit certain safety information, such as contraindications or warnings, that is protected by exclusivity under existing law. The bill requires the Secretary of Health and Human Services to include a statement of any appropriate safety information in the labeling of such approved generic drugs. The bill does not affect the availability or scope of exclusivity for other aspects of labeling protected by existing law.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (1)
Last Action
Referred to the Subcommittee on Health. (on 04/27/2021)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location |
|---|---|
| State Bill Page | https://www.congress.gov/bill/117th-congress/house-bill/2831/all-info |
| BillText | https://www.congress.gov/117/bills/hr2831/BILLS-117hr2831ih.pdf |
| Bill | https://www.congress.gov/117/bills/hr2831/BILLS-117hr2831ih.pdf.pdf |
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