FDA Guidance Documents Update

Recently posted guidance documents:

7/7/16: Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

7/7/16: Compounded Drug Products That Are Essentially Copies of Approved Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

7/8/16: Updating ANDA Labeling After the Marketing Application for the Reference Listed Drug Has Been Withdrawn Guidance for Industry

7/8/16: Use of Standards in FDA Regulatory Oversight of Next Generation Sequencing (NGS)-Based In Vitro Diagnostics (IVDs) Used for Diagnosing Germline Diseases - Draft Guidance for Stakeholders and Food and Drug Administration Staff

7/8/16: Use of Public Human Genetic Variant Databases to Support Clinical Validity for Next Generation Sequencing (NGS)-Based In Vitro Diagnostics - Draft Guidance for Stakeholders and Food and Drug Administration Staff

7/11/16: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices - Guidance for Industry and Food and Drug Administration Staff

7/13/16:Bacterial Vaginosis: Developing Drugs for Treatment Guidance for Industry

7/15/16: Principles for Codevelopment of an In Vitro Companion Diagnostic Device with a Therapeutic Product - Draft Guidance for Industry and Food and Drug Administration Staff

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