FDA commissioner Stephen Hahn uses a Washington Post op-ed to reassure the public that any Covid-19 authorized for widespread use will be thoroughly e...
The Justice Department says a federal grand injury has indicted eight people in a scheme to falsify FDA clinical trial data.
More than 250 scientific experts say FDA must thoroughly evaluate the completed Phase 3 trial results of any Covid-19 vaccine before the vaccine is ma...
FDA has scheduled the next in a series of virtual town halls to answer questions on developing coronavirus diagnostic tests for 8/12.
The White House says President Trump is signing an Executive Order to increase American production of essential medical supplies and cut down U.S. rel...
FDA clears a Surmodics 510(k) for its Sublime Radial Access 0.014 Rapid Exchange percutaneous transluminal angioplasty dilatation catheter.
Federal Register notice: FDA seeks comments on an information collection entitled Extralabel Drug Use for Animals 21 CFR 530.
Reuters reports that the Justice Department is asking for nearly $13 billion to resolve charges against Purdue Pharma and its Sackler family owners.