FDA schedules a 3/22 virtual public meeting to discuss its final assessment of the BsUFA Program for Enhanced Review Transparency and Communication.
FDA announces the publication of 30 new and 13 revised product-specific guidances to promote generic drug development.
Jones Day attorneys outline Sen. Thom Tillis request for an independent study of data on drug companies using the patent system to delay competition a...
FDA clears a Tandem Diabetes Care 510(k) for bolus insulin dosing on the t:slim X2 insulin pump using the t:connect mobile app.
Federal Register notice: FDA seeks comments about antimicrobial drug use practices in companion animals and the potential impacts on antimicrobial res...
Federal Register notice: FDA announces a 5/9-10 public workshop entitled FY 2022 Generic Drug Science and Research Initiatives Workshop.
Members of two FDA advisory committees say Avenue Therapeutics IV Tramadol has risks that exceed benefits.
An online CBER report describes Center collaborative efforts with international partners on Covid-19.