FDA Guidance Documents Update

Recently posted guidance documents:

4/14/16: Data Integrity and Compliance With Current Good Manufacturing Practice Guidance for Industry

4/15/16: Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act Guidance for Industry

4/15/16: Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act

4/15/16: Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry (PDF - 296KB)

4/18/16: Radiation Biodosimetry Medical Countermeasure Devices - Guidance for Industry and Food and Drug Administration Staff

4/19/16: Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information Guidance for Industry

4/20/16: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices - Guidance for Industry and Food and Drug Administration Staff

4/22/16: Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products

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