FDA Guidance Documents Update

Recently posted guidance documents:

2/16/16: Recommendations for Donor Screening, Deferral, and Product Management to Reduce the Risk of Transfusion-Transmission of Zika Virus; Guidance for Industry

2/18/26: Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry

2/18/16: Determining the Extent of Safety Data Collection Needed in Late Stage Premarket and Postapproval Clinical Investigations

2/22/16: Guidance for Industry: Nutrient Content Claims; Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids; Small Entity Compliance Guide

2/29/16: Labeling for Permanent Hysteroscopically-Placed Tubal Implants Intended for Sterilization - Draft Guidance for Industry and Food and Drug Administration Staff

2/29/16: Requirements for Transactions with First Responders under Section 582 of the Federal Food, Drug, and Cosmetic Act— Compliance Policy Guidance for Industry

3/1/16: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies; Draft Guidance for Industry

3/3/16: Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products; Guidance for Industry

3/4/16: Environmental Assessment: Questions and Answers Regarding Drugs With Estrogenic, Androgenic, or Thyroid Activity

3/7/16: Medical Devices and Clinical Trial Design for the Treatment or Improvement in the Appearance of Fungally-Infected Nails - Guidance for Industry and Food and Drug Administration Staff

3/7/16: Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes - Draft Guidance for Industry and Food and Drug Administration Staff

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