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Enhancing Participation in Clinical Trials — Eligibility Criteria, Enrollment Practices, and Trial Designs-2025/12/15

Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers-2025/12/9

eCopy Program for Medical Device Submissions-2025/12/3

QTc Information in Human Prescription Drug and Biological Product Labeling-2025/12/3

Monoclonal Antibodies: Streamlined Nonclinical Safety Studies-2025/12/2

Current Good Manufacturing Practice for Medical Gases-2025/11/28

Q3E Guideline for Extractables and Leachables-2025/11/28

QE3 Guideline for Extractables and Leachables: Supporting Documentation: Class 3 Leachable Monographs-2025/11/28

Cross-Center Master Files: Where to Submit-2025/11/25