On September 4, 2025, the U.S. Food and Drug Administration (“FDA”) announced plans to begin releasing complete response letters (“CRLs”) “promptly” after it issues them to sponsors, rather than waiting until after approval....more
9/12/2025
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On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more