FDA Guidance Documents Update

Recently posted guidance documents

8/27/15: Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile - Guideline for Industry and Food and Drug Administration Staff

8/27/15: Nonproprietary Naming of Biological Products Guidance for Industry

8/27/15: Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products; Guidance for Industry

9/1/15: VICH GL53 - Electronic Exchange of Documents: File Format Recommendations

9/1/15: CVM GFI #227 - Two-Phased Chemistry, Manufacturing, and Controls (CMC) Technical Sections

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