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...
FDA cancels a scheduled meeting with the National Treasury Employees Union, which represents thousands of FDA staff, to discuss the impact of layoffs ...
FDA approves an RM Pharma 505(b)(2) for HemiClor (12.5 mg chlorthalidone) tablets for treating hypertension in adults.
FDA commissioner Martin Makary reiterates that he wants to see clinical trials for new Covid vaccine boosters.
FDA clears a Teleflex 510(k) for an expanded indication for its QuikClot Control+ Hemostatic Device to include all grades of internal and external ble...
Genentech researchers say FDAs Drug Development Tools Qualification program has had a very limited impact on development programs.
Public health researchers warn about the broader impacts to emerging technologies (e.g., artificial intelligence) in a March court ruling that struck ...
