FDA Guidance Document Update

Recently Posted Guidance Documents

Animal and Veterinary

12/20/16: CVM GFI #234 Question-Based Review for the Chemistry, Manufacturing, and Controls Technical Section Of Animal Drug Applications

1/4/17: CVM GFI #242 In-Use Stability Studies and Associated Labeling Statements for Multiple-Dose Injectable Animal Drug Products

1/5/17: VICH GL56 - CVM GFI #243 Study Design Recommendations for Residue Studies in Honey for Establishing Maximum Residue Limits and Withdrawal Periods

Biologics

1/3/17: Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Draft Guidance for Industry

Drugs

12/21/16: ANDA Submissions -- Refuse-to-Receive Standards Rev.2

12/28/16: Compounding and Repackaging of Radiopharmaceuticals By Outsourcing Facilities Guidance for Industry

12/28/16: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies and Federal Facilities Guidance for Industry

12/28/16: Providing Regulatory Submissions in Electronic Format--Submission of Manufacturing Establishment Information Guidance for Industry

12/28/16: Botanical Drug Development: Guidance for Industry

12/28/16: Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

12/28/16: Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance for Industry

12/30/16: Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

FDA Operations

12/16/16: Gifts to FDA: Evaluation and Acceptance

Food

1/4/17: Questions and Answers on the Nutrition and Supplement Facts Labels Related to the Compliance Date, Added Sugars, and Declaration of Quantitative Amounts of Vitamins and Minerals, Draft Guidance for Industry

1/4/17: Reference Amounts Customarily Consumed: List of Products for Each Product Category, Draft Guidance for Industry

Medical Devices

12/27/16: Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions - Guidance for Industry and Food and Drug Administration Staff

12/28/16: Postmarket Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff

12/30/16: Medical Device Accessories - Describing Accessories and Classification Pathway for New Accessory Types - Guidance for Industry and Food and Drug Administration Staff

1/3/17: Premarket Notification (510(k)) Submissions for Bone Anchors - Draft Guidance for Industry and Food and Drug Administration Staff

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