FDA Releases Draft Guidance for Manufacturing Primary Batches of New Animal Drug Products

Summary

The Food and Drug Administration (FDA) has released a draft guidance document (GFI #285) outlining recommendations for manufacturing primary batches of new animal drug products to support their approval or conditional approval. The guidance applies to original new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), and conditional new animal drug applications (CNADAs).