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FDA Releases CMC Postapproval Manufacturing Changes For Specified Biological Products To Be Documented In Annual Reports

Published: February 22, 2022

This new FDA/CDER guidance represents the FDA's thinking regarding the types of changes to an approved biologics license application (BLA) that...

Source: lifescienceleader.com

Related Topics:

Mark DurivageOffice Of CommunicationInternational Council For HarmonisationOffice Of Pharmaceutical QualityQuality Systems ComplianceDrug EvaluationBiologics EvaluationManufacturing ChangesSpecified Biological Products To Be DocumentedAnnual ReportsInternational CouncilManufacturing Practice GuidanceActive Pharmaceutical IngredientsRisk ManagementQuality SystemFederal FoodCosmetic ActApproval Supplement Expedited Review RequestedChanges ThatConsiders HavingApproved ApplicationSpecified BiotechnologySpecified Synthetic Biological ProductsPharmaceutical Quality