Bill
Bill > HR4955
summary
Introduced
10/31/2019
10/31/2019
In Committee
11/01/2019
11/01/2019
Crossed Over
Passed
Dead
12/31/2020
12/31/2020
Introduced Session
116th Congress
Bill Summary
A BILL To amend the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a new chemical entity. 1
AI Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to clarify the meaning of a "new chemical entity." Specifically, it replaces references to "active ingredient" with "active moiety" (the molecule or ion responsible for the physiological or pharmacological action of a drug substance) in various sections of the Act related to drug approvals and exclusivities. This change aligns the language in the Act with the definition of "active moiety" used by the Food and Drug Administration in its regulations.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (4)
Last Action
Referred to the Subcommittee on Health. (on 11/01/2019)
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/116th-congress/house-bill/4955/all-info |
| BillText | https://www.congress.gov/116/bills/hr4955/BILLS-116hr4955ih.pdf |
| Bill | https://www.congress.gov/116/bills/hr4955/BILLS-116hr4955ih.pdf.pdf |
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