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- FDA appoints permanent heads for CDER and CBER amid pending commissioner confirmationThe Department of Health and Human Services announced that Michael Davis, MD, PhD, and Karim Mikhail will become the permanent directors of the Centers for Drugs Evaluation and Research and the Cen…
- Researchers urge FDA to adopt EMA-style drug rejection letter disclosuresThe FDA began publishing letters that explain why a drug application was denied in September 2025, marking a significant transparency shift. Researchers argue that the agency’s current disclosures…