GDF2026 - Quality and Safety Assessment of Extractables/Leachables in Generic Drug Products
U.S. Food and Drug Administration, Office of Generic Drugs (OGD) · July 30, 2026
FDA Office of Generic Drugs staff presented guidance for applicants on extractables and leachables, outlining how to use prior knowledge, regulatory references, and safety thresholds to limit unnecessary testing and avoid common review deficiencies.
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