summary
Introduced
06/13/2022
06/13/2022
In Committee
06/13/2022
06/13/2022
Crossed Over
Passed
Dead
01/03/2023
01/03/2023
Introduced Session
117th Congress
Bill Summary
A BILL To reauthorize a provision of the Federal Food, Drug, and Cosmetic Act pertaining to drugs containing single enantiomers.
AI Summary
This bill, the Hatch-Waxman Improvement Act of 2022, seeks to reauthorize a provision of the Federal Food, Drug, and Cosmetic Act that pertains to drugs containing single enantiomers. Specifically, it amends the Act to clarify that the provision applies to clinical investigations other than bioavailability studies, and extends the provision's expiration date from October 1, 2022 to October 1, 2027. This extension allows for the continued application of the provision, which provides a regulatory pathway for the approval of certain drug products containing single enantiomers, a specific type of molecular structure.
Committee Categories
Health and Social Services
Sponsors (1)
Last Action
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (on 06/13/2022)
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/4378/all-info |
| BillText | https://www.congress.gov/117/bills/s4378/BILLS-117s4378is.pdf |
| Bill | https://www.congress.gov/117/bills/s4378/BILLS-117s4378is.pdf.pdf |
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