Determining Whether to Submit an ANDA or a 505(b)(2) Application-2026/8/17

CVM GFI #260 - Type VII Veterinary Master File for Research and Development and Risk Reviews-2026/8/14

Container Closure Systems for Human Drugs and Biological Products-2026/8/13

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products-2026/8/12

Guidance for Industry: Guide to Minimize Biological Hazards in Ready-to-Eat Fresh-Cut Produce-2026/8/11

CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern-2026/8/5

Applying Human Factors and Usability Engineering to Medical Devices-2026/8/3

Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs-2026/7/31

Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs-2026/7/31

Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts-2026/7/31