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
ProRx, LLC – 696742 – 12/20/2024
Compounding Pharmacy/Adulterated Drug Products
Kardesler Ucan Yaglar Sanayi Anonim Sirketi – 695413 – 01/21/2025
CGMP/Finished Pharmaceutical/Adulterated
Americo F. Padilla, M.D./Miami Dade Medical Research Institute – 700447 – 01/17/2025
Clinical Investigator
Mihon Corp. d/b/a VitalityVita and Boulla, LLC – 698165 – 01/16/2025
Unapproved New Drugs/Misbranded
Ocean rates drop as January demand cools
A rebound could manifest due to tariff concerns and continued trepidation about shipping through the Red Sea.
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,…