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- Upcoming Product-Specific Guidances for Generic Drug Product Development May 14, 2024This web page provides information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products.FDA
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- After filing hitch, Eisai and Biogen begin rolling FDA submission for subcutaneous Leqembi May 14, 2024After filing hitch, Eisai and Biogen begin rolling FDA submission for subcutaneous Leqembi fkansteiner Tue, 05/14/2024 - 17:41fkansteiner