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- 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…
- FDA offers guidance for smoother BLA submissions and outlines biosimilar review changesSubmitting a biologics license application requires early interaction with the FDA's Office of Therapeutic Products, careful preparation to avoid technical and administrative mistakes, and keeping…