PDUFA Performance Reports
PDUFA Performance Reports
Nearly 3 in 4 workers say they can only meet their basic living expenses
Salaries not keeping up with inflation is one culprit of employees’ financial stress, according to a Resume Now report.
Ericsson touts ‘broad-based production’ as tariff deterrent
The telecommunications company invested $50 million in its U.S. factory over the last two years as it navigates a shifting…
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
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