FDA Guidance Document Update

Recently posted guidance documents Drugs 9/20/16: FDA’s Application of Statutory Factors in Determining When a REMS Is Necessary Guidance for Industry 9/21/16: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - Draft Guidance for Industry and Food and Drug Administration Staff 9/22/16: Self-Identification of Generic Drug Facilities, Sites, and Organizations; Guidance for Industry 9/30/16: Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients Guidance for Industry Medical Devices 9/21/16: Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - Draft Guidance for Industry and Food and Drug Administration Staff 9/21/16: Reporting of Computational Modeling Studies in Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff Animal & Veterinary 9/22/16: CVM GFI #233 Veterinary Feed Directive Common Format Questions and Answers Foods 9/22/16: Use of the Term "Healthy" in the Labeling of Human Food Products, Guidance for Industry Guidance Document Search: Search all FDA official guidance documents and other regulatory guidance