FDA Guidance Document Update

Recently Posted Guidance Documents

Animal & Veterinary

11/1/16: CVM GFI #241 - Small Entity Compliance Guide - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

11/2/16: CVM GFI #170 Animal Drug User Fees and Fee Waivers and Reductions

Drugs

11/7/16: Non-Inferiority Clinical Trials

Medical Devices

11/7/16: Clinical Considerations for Investigational Device Exemptions (IDEs) for Neurological Devices Targeting Disease Progression and Clinical Outcomes - Guidance for Industry and Food and Drug Administration Staff

11/8/16: Medical Device Reporting for Manufacturers - Guidance for Industry and Food and Drug Administration Staff

11/10/16: Product Labeling for Certain Ultrasonic Surgical Aspirator Devices - Draft Guidance for Industry and Food and Drug Administration Staff

Guidance Document Search:

• Search all FDA official guidance documents and other regulatory guidance