What FDA PDUFA VII Performance Goals and Procedures 2023-2027 requires
The FDA PDUFA VII requires prescription drug manufacturers to meet specific performance goals and procedures for the review of new drug applications, as outlined in Section 735(1) of the Federal Food, Drug, and Cosmetic Act.
Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration · Version: 1.0.1 · Last updated:
Primary source: https://www.fda.gov/industry/prescription-drug-user-fee-amendments/pdufa-vii-fiscal-years-2023-2027
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Primary Citations — 6 traced to source
- Federal Food, Drug, and Cosmetic Act, Section 735(1)
- PDUFA VII Performance Goals and Procedures 2023-2027, Goal 1: Review Timelines
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