Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry-2025/9/8

E6(R3) Good Clinical Practice (GCP)-2025/9/8

Classification Categories for Certain Supplements Under BsUFA III-2025/9/8

Withdrawn Guidances (Biologics)-2025/8/27

CVM GFI #236 Clarification of FDA and EPA Jurisdiction Over Mosquito-Related Products-2025/8/27

Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions-2025/8/22

Oncology Therapeutic Radiopharmaceuticals: Dosage Optimization During Clinical Development-2025/8/19

Approaches to Assessment of Overall Survival in Oncology Clinical Trials-2025/8/19

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions-2025/8/18

CVM GFI #294 - Animal Food Ingredient Consultation (AFIC)-2025/7/31