Bill
Bill > S4535
US S4535
US S4535FDASRA Act of 2022 Food and Drug Administration Simple Reauthorization Act of 2022 Biosimilar User Fee Amendments of 2022 Generic Drug User Fee Amendments of 2022 Medical Device User Fee Amendments of 2022 Prescription Drug User Fee Amendments of 2022
summary
Introduced
07/14/2022
07/14/2022
In Committee
07/14/2022
07/14/2022
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 revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar bio- logical products, and for other purposes.
AI Summary
This bill, the Food and Drug Administration Simple Reauthorization Act of 2022 (FDASRA Act of 2022), reauthorizes and amends several user fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products at the Food and Drug Administration (FDA). The bill extends the authorization of these user fee programs, which provide funding for the FDA's review and oversight activities, from 2022 through 2027. The bill also makes adjustments to the fee amounts, fee revenue targets, and other provisions related to these user fee programs. Additionally, the bill reauthorizes several other FDA programs, including the Critical Path public-private partnership, the Best Pharmaceuticals for Children program, and the Orphan Drug grants.
Committee Categories
Health and Social Services
Sponsors (1)
Last Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 07/14/2022)
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/senate-bill/4535/all-info |
| BillText | https://www.congress.gov/117/bills/s4535/BILLS-117s4535is.pdf |
| Bill | https://www.congress.gov/117/bills/s4535/BILLS-117s4535is.pdf.pdf |
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