Federal Register notice: CDER and CDRH announce a two-day (5/9-10) public conference entitled FDA Small Business and Industry Assistance Regulatory Ed...
FDA expands the use of Bayers Stivarga (regorafinib) to include treating patients with hepatocellular carcinoma who have been previously treated with ...
Federal Register notice: FDA seeks comments on a report evaluating pediatric studies of ampicillin.
Federal Register notice: FDA seeks comments on a new information collection on Certification of Identity for Freedom of Information Act (FOIA) and Pri...
The Senate Health, Education, Labor & Pensions (HELP) Committee postpones a vote until 4/27 on Scott Gottlieb to be the next FDA commissioner.
Reps. Ann Kuster (D-NH) and Mimi Walters (R-CA) introduce HR 2144 that would require FDA to implement an efficient, streamlined process for classifyin...
FDA issues a draft product-specific guidance for generic Narcan products as it accepts in part and denies in part several specific requests the NDA ho...
Federal Register notice: FDA, the National Science Foundation and Department of Homeland Security, Science and Technology announce a public workshop e...