Madrigal Pharmaceuticals says its resmetirom met FDA-suggested endpoints in the pivotal Phase 3 MAESTRO-NASH trial to treat nonalcoholic steatohepatit...
Rep. Abigail Spanberger asks FDA and the DEA how they will work together and independently to overcome the current shortage of Adderall.
Two JAMA articles say FDA should seek to tweak its accelerated approval program to make it easier for it to pull an approval if a confirmatory study d...
Federal Register notice: FDA is releases a draft guidance entitled Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers.
Federal Register notice: FDA posts a draft guidance entitled Content of Human Factors Information in Medical Device Marketing Submissions.
Federal Register proposed rule: FDA proposes to amend its regulations on INDs to exempt certain clinical investigations of lawfully marketed foods for...
Federal Register proposed rule: FDA proposes to replace its current annual reporting requirement for INDs with a new requirement: the annual FDA devel...
Remel recalls Thermo Scientific Gram Negative IVD AST Sensititre Plates due to the risk of potential false susceptible results for Proteae Tribe.
