To amend section 505(j) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)) with respect to a process to inform persons submitting an abbreviated application for a new drug whether the new drug is qualitatively or quantitatively the same as a listed drug, and for other purposes.
Increasing Transparency in Generic Drug Applications Act of 2022
This bill requires the Food and Drug Administration to inform generic drug applicants, upon request or during review, whether the drug is qualitatively and quantitatively the same as the listed brand-name drug (and if not, the reasons why).
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