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- FDA proposes new BsUFA IV commitment letter to streamline biosimilar reviewsThe U.S. Food and Drug Administration released a draft commitment letter for the Biosimilar User Fee Act (BsUFA IV) program, highlighting several departures from the existing biosimilar review fram…
- FDA CDER chief says expanding generic GLP-1 drugs is top priority to cut American costsMichael Davis, director of the FDA's Center for Drug Evaluation and Research, highlighted that increasing the supply of generic GLP-1 medicines is a key focus for the agency. He noted that broader…