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FDA Guidance Documents Update Nov. 2015 on Devices, Animal Studies, Gene Therapy, Liposomes

November 3, 2015 by sjwilliamspa

FDA Guidance Documents Update

Reporter: Stephen J. Williams, Ph.D.

10/30/2015

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Recently posted guidance documents

10/14/15: General Considerations for Animal Studies for Medical Devices – Draft Guidance for Industry and Food and Drug Administration Staff

10/14/15: Recommendations for Microbial Vectors Used for Gene Therapy; Draft Guidance for Industry

10/15/15: Draft PDEs for Triethylamine and for Methylisobutylketone

10/15/15: ICH Q3C Maintenance Procedures for the Guidance for Industry Q3C Impurities: Residual Solvents

10/19/15: CVM GFI #229 – Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle

10/21/15: Selection of the Appropriate Package Type Terms and Recommendations for Labeling Injectable Medical Products Packaged in Multiple-Dose, Single-Dose, and Single-Patient-Use Containers for Human Use

10/21/15: Manufacturing Site Change Supplements: Content and Submission – Draft Guidance for Industry and Food and Drug Administration Staff

10/26/15: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

10/26/15: Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act

10/26/15: Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance

10/27/15: Nonclinical Safety Evaluation of Reformulated Drug Products and Products Intended for Administration by an Alternate Route

10/27/15: Product Development Under the Animal Rule

10/28/15: DSCSA Implementation: Product Tracing Requirements for Dispensers — Compliance Policy (Revised) Guidance for Industry

10/29/15: Liposome Drug Products: Chemistry, Manufacturing, and Controls; Human Pharmacokinetics and Bioavailability; and Labeling Documentation

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Posted in FDA, FDA Regulatory Affairs, FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning - GCP, GLP, ISO 14155, Lipidomics, Liposome, Pharmaceutical Discovery, Pharmaceutical Drug Discovery, Uncategorized | Tagged animal testing, Clinical trial, FDA, Food and Drug Administration, gene therapy, health | Leave a Comment

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