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

Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use-2025/11/17

How to Prepare a Pre-Request for Designation (Pre-RFD)-2025/11/6