FDA issues an immediately effective guidance with questions and answers on drug formal meetings and user fee applications during the Covid-19 emergenc...
FDA is reportedly investigating MicroGen DX over questionable Covid-19 test results reported to AdventHealth.
Public Citizen and Lower Drug Prices Now call for the designation of vaccine czar Moncef Slaoui as a special government employee subject to conflict o...
FDA says it no longer plans to hold an Oncologic Drugs Advisory Committee meeting to consider the MacroGenics BLA for margetuximab to treat some breas...
FDA says it has added diabetes drug metformin to its watch list of drugs with potential safety concerns after a cancer-causing impurity was detected i...
FDA clears a Gynesonics 510(k) to market its next generation Sonata System 2.1 for Transcervical Fibroid Ablation.
U.S. senators Joni Ernst (R-IA) and Chuck Grassley (R-IA) write to FDA asking for clarification on its temporary policy for manufacturing alcohol-base...
Federal Register notice: FDA makes available draft recommendations for new permitted daily exposures (PDEs) for the residual solvents 2-methyltetrahyd...