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Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

While generic drugs technically pre-dated the law (look up “Paper NDAs” if you’re interested), the law turbocharged the ability of generics to come to market. While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. Read the full list of documents on FDA’s Unified Agenda here.]

FDA 40
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Analysis Life Sciences Thank You The 53 regulations that FDA is currently working on

Agency IQ

Proposed Rule Pediatric Study Plan Requirements for New Drug and Biologics License Applications October 2024 FDA is proposing to amend its existing regulations and add new regulations pertaining to submission of required initial pediatric study plans (iPSPs) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). and the E.C.