Tag: FDA

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FDA Update: Navigating Regulatory Volatility—and Leveraging the DoD Dual Regulatory Pathway

In a regulatory environment shaped by leadership turnover, evolving review practices, and policy shifts announced outside traditional channels, companies developing FDA-regulated medical products are...

FDA Commissioner Shares Unfiltered Vision for a Modern FDA with Maryland Industry Leaders

FDA Commissioner Dr Makary Shares Unfiltered Vision for a Modern FDA with Maryland Industry Leaders

Industry Concerns Elevated after FDA’s top Biologics Reviewer Resigns Following Reversal of Gene Therapy Halt

Dr. Vinay Prasad, the FDA’s Chief Medical and Scientific Officer and head of the Center for Biologics Evaluation and Research (CBER), resigned abruptly on July 29

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