Recently Posted Guidance Documents on Drugs, Devices, Veterinary

Drugs

6/15/2018  Epidermolysis Bullosa: Developing Drugs for Treatment of Cutaneous Manifestations; Draft Guidance for Industry

6/15/2018 S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers

6/13/2018  Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis

6/12/2018 Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers Guidance for Industry and Review Staff

6/12/2018  Patient-Focused Drug Development: Collecting Comprehensive and Representative Input

6/12/2018 Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers Guidance for Industry

6/12/2018  Limited Population Pathway for Antibacterial and Antifungal Drugs Guidance for Industry

Devices

6/15/2018 Logical Observation Identifiers Names and Codes for In Vitro Diagnostic Tests - Guidance for Industry and Food and Drug Administration Staff

6/15/2018  Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings - Labeling Considerations - Draft Guidance for Industry and Food and Drug Administration Staff

6/15/2018 Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling - Draft Guidance for Industry and Food and Drug Administration Staff

6/13/2018  Humanitarian Device Exemption (HDE) Program - Draft Guidance for Industry and Food and Drug Administration Staff

Veterinary

6/15/2018 CVM GFI #246 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply-Chain Program

6/12/2018 CVM GFI #3 General Principles for Evaluating the Human Food Safety of New Animal Drugs Used In Food-Producing Animals