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

Agency IQ

JULY 8, 2024

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

FDA 40
FDA Science Regulations Production 40
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Analysis Life Sciences Thank You What We Expect the FDA to do in August and September 2024

Agency IQ

AUGUST 2, 2024

Letter Program Tag Commitment Due Date MDUFA International Harmonization Commencing with FY 2024, publish an annual assessment of the international harmonization activities described the strategic plan due by the end of FY 2023.

FDA 40
FDA Science Regulations Biosimilars 40
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Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Agency IQ

MAY 3, 2024

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 (..)

FDA 40
FDA Science Regulations Clinical Trials 40
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