Zdrowie i gospodarka · 17/09/2024

FDA Announces Draft Guidance for Chemistry, Manufacturing, and Controls Technical Section Filing Strategies

The FDA has released a draft guidance document (GFI #227) outlining strategies for submitting Chemistry, Manufacturing, and Controls (CMC) data to support new animal drug applications, with the goal of soliciting early input from the Center for Veterinary Medicine (CVM).

Source: Federal Register — Food and Drug AdministrationOpen original release →

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