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
Americo F. Padilla, M.D./Miami Dade Medical Research Institute – 700447 – 01/17/2025
Clinical Investigator
Kardesler Ucan Yaglar Sanayi Anonim Sirketi – 695413 – 01/21/2025
CGMP/Finished Pharmaceutical/Adulterated
ProRx, LLC – 696742 – 12/20/2024
Compounding Pharmacy/Adulterated Drug Products
Mihon Corp. d/b/a VitalityVita and Boulla, LLC – 698165 – 01/16/2025
Unapproved New Drugs/Misbranded
Cost Minimized Immunoaffinity Purification of EPO and Its Analogs in Doping Control—A Step‐by‐Step Protocol for Human Urine and Blood
A cost minimized immunoaffinity protocol was developed, which allows the direct purification of ERAs from human urine. After slight modification,…
Cost Minimized Immunoaffinity Purification of EPO and Its Analogs in Doping Control—A Step‐by‐Step Protocol for Human Urine and Blood
A cost minimized immunoaffinity protocol was developed, which allows the direct purification of ERAs from human urine. After slight modification,…
About CDER Center for Clinical Trial Innovation (C3TI)
C3TI brings together collective expertise and activities to foster integration and coordination across the different ongoing projects and initiatives within…