FDA provides a voluntary EUA template for device developers to use for Covid-19 at-home sample collection kits.
FDA says five drug firms will need to recall their metformin drug products after sampling detected an impurity (N-Nitrosodimethylamine) above the agen...
FDA issues a draft guidance answering commonly asked questions about the drug product Orange Book.
An FDLI article explains major CARES Act provisions reforming the OTC monograph system.
Federal Register notice: FDA makes available a revised guidance entitled Submission of Plans for Cigarette Packages and Cigarette Advertisements (Revi...
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...