FDA announces a 5/22 Vaccines and Related Biological Products Advisory Committee meeting to discuss and make recommendations on the selection of the 2...
CBS News reports that FDA associate commissioner for inspections and investigations Michael Rogers is retiring, frustrated over changes being made by ...
FDA taps former Booz Allen Hamilton chief technologist Jeremy Walsh to lead its artificial intelligence (AI) and information technology efforts in a n...
FDA approves Teva Pharmaceuticals and Alvotechs Selarsdi injection as an interchangeable biosimilar to Janssens reference biologic Stelara (ustekinuma...
FDA says it is expanding the use of unannounced inspections of foreign medical product and food manufacturing facilities.
President Trump signs an Executive Order requiring FDA to take steps to increase domestic drug manufacturing.
FDA appoints University of California, San Francisco professor Vinay Prasad to serve as CBERs new director, replacing Peter Marks, who abruptly resign...
An FDA Webinar discusses drug study information in NDAs/BLAs that will need to be electronically submitted in a certain format to assist FDA in planni...