Postmarketing Requirements and Commitments: Searchable Database
Learn more about FDA’s Postmarketing Requirements and Commitments Searchable Database.
Joint US FDA – Health Canada ICH Public Meeting – 02/22/2024
Joint US FDA – Health Canada ICH Public Meeting
Characterization and Identification of Commercial Synthetic Urine Products
Automated microscopy was validated as a specimen validity test for urine. Over 99% of 1127 outpatient urine specimens contained cells…
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies
This draft guidance describes considerations regarding a comparative clinical study or studies with efficacy endpoints (a comparative efficacy study or…
CANCELED – 17th Annual Sentinel Initiative Public Workshop – 11/06/2025
The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the…
POSTPONED – 17th Annual Sentinel Initiative Public Workshop – 11/06/2025
The U.S. Food and Drug Administration, under a cooperative agreement with the Duke-Margolis Institute for Health Policy, is hosting the…
The Tranzonic Companies/Innocore Sales & Marketing Inc. – 712258 – 10/16/2025
CGMP/Finished Pharmaceuticals/Adulterated
Mapping of the Pharmacological Effect of Prohibited Substances and Methods to Athletic Physiological Characteristics
Expected performance benefits for each prohibited substance/method has been presented. Several disciplines are highlighted as an example. The y$$ y…
Pediatrics and Maternal Health
DPMH oversees quality initiatives which promote and necessitate the study of drug and biological products in the pediatric population and…
Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development – 05/29/2024
Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development