Bill
Bill > HR7032
summary
Introduced
03/09/2022
03/09/2022
In Committee
03/10/2022
03/10/2022
Crossed Over
Passed
Dead
01/03/2023
01/03/2023
Introduced Session
117th Congress
Bill Summary
A BILL To amend section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) with respect to a proc- ess to inform persons submitting an abbreviated applica- tion for a new drug whether the new drug is qualitatively or quantitatively the same as a listed drug, and for other purposes.
AI Summary
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to inform a person who has submitted or intends to submit an abbreviated application for a new generic drug whether the new drug is qualitatively and quantitatively the same as the listed drug. If the new drug is not the same, the Secretary must identify the ingredients that cause the difference and the quantity or proportion of any ingredient in the listed drug that has a quantitative deviation. The bill also requires the Secretary to issue guidance on how to determine if a new drug is qualitatively and quantitatively the same as the listed drug, including with respect to assessing pH adjusters.
Committee Categories
Business and Industry, Health and Social Services
Sponsors (2)
Last Action
Referred to the Subcommittee on Health. (on 03/10/2022)
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/house-bill/7032/all-info |
| BillText | https://www.congress.gov/117/bills/hr7032/BILLS-117hr7032ih.pdf |
| Bill | https://www.congress.gov/117/bills/hr7032/BILLS-117hr7032ih.pdf.pdf |
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