Medical Device User Fee Small Business Qualification and Determination -2025/7/31

E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials-2025/7/21

Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry-2025/7/18

Development of Cancer Drugs for Use in Novel Combination - Determining the Contribution of the Individual Drugs’ Effects-2025/7/17

Recommendations for Testing Blood Donations for Hepatitis B Surface Antigen-2025/7/15

Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations-2025/7/3

Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment-2025/7/2

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions-2025/6/27

Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers-2025/6/26

Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment-2025/6/26