Bill
Bill > HR1857
summary
Introduced
03/11/2021
03/11/2021
In Committee
03/12/2021
03/12/2021
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 clarify the meaning of a new chemical entity.
AI Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a "new chemical entity" by replacing references to "active ingredient" with "active moiety" throughout the Act. The "active moiety" is defined by the Secretary of Health and Human Services in the Code of Federal Regulations. This change affects various sections of the Act, including provisions related to exclusivity periods for new drugs, approvals of animal drugs, and incentives for rare disease treatments. The purpose of this bill is to provide clarity and update the language used in the Act to better reflect the current scientific understanding of drug composition and development.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (2)
Last Action
Referred to the Subcommittee on Health. (on 03/12/2021)
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/1857/all-info |
| BillText | https://www.congress.gov/117/bills/hr1857/BILLS-117hr1857ih.pdf |
| Bill | https://www.congress.gov/117/bills/hr1857/BILLS-117hr1857ih.pdf.pdf |
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