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

Agency IQ

Letter Program Tag Commitment Due Date PDUFA Advancing RWE Program Report containing aggregated and anonymized information describing RWE submissions to CDER and CBER.

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Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

Patrizia Cavazzoni Patrizia Cavazzoni May 6 Friends of Cancer Research; Parker Institute for Cancer Immunotherapy Unlocking Complex Cell-based Gene Therapies Peter Marks, Namandjé Bumpus, Nicole Verdun, Iwen Wu, Asha Das, Anna Kwilas, May 6-9 Association of Public Health Laboratories APHL Annual Conference Numerous May 7 Reagan-Udall Foundation for (..)

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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. We expect the FDA to mark the occasion, especially since drug pricing continues to be such a potent issue in the Presidential election. and the E.C.

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