Bioiberica, SAU – 629115 – 01/15/2025
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Bioiberica, SAU – 629115 – 06/30/2022
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
Administration Studies in Equine Antidoping Research: Designing Scientific Investigations to Effectively Direct Medication Control in Racehorses
ABSTRACT Pharmacokinetics is the study of the movement of drug in the body and includes the processes of absorption, distribution,…
Registered Outsourcing Facilities
Discover FDA’s comprehensive list of registered outsourcing facilities engaged in human drug compounding. Get the latest updates, compliance guidelines, and…
PDUFA Performance Reports
PDUFA Performance Reports
Industry Information and Guidance
FDA review of biosimilar and interchangeable products requires a 351(k) biologics license application that includes information demonstrating biosimilarity.
Biosimilars | Science and Research
Learn about FDA’s latest in biosimilar science and research.
BsUFA III Regulatory Science Pilot Program: Progress Update – 01/22/2025
BsUFA III Regulatory Science Pilot Program: Progress Update
Mihon Corp. d/b/a VitalityVita and Boulla, LLC – 698165 – 01/16/2025
Unapproved New Drugs/Misbranded
