FDA updates its List of Off-Patent, Off-Exclusivity Drugs without an Approved Generic.
FDA Review posts the Federal Register notices for the week ending 6/21/2019.
FDA Review posts product approval summaries for the week ending 6/21/2019.
Federal Register notice: FDA announces that it issued a priority review voucher to AveXis for gaining approval for its rare pediatric disease product ...
FDA acting commissioner Ned Sharpless tells the Washington Post that he would like to be nominated by President Trump as the next agency commissioner.
FDA expands the indication of Vertex Pharmaceuticals Symdeko (tezacaftor/ivacaftor) tablets for treating pediatric patients aged six years and older w...
Federal Register notice: FDA announces an 8/7 Antimicrobial Drugs Advisory Committee meeting to discuss a Gilead Sciences supplemental NDA for Descovy...
In an online post, CDRH director Jeff Shuren discusses the end to the Centers Alternative Summary Reporting program and other changes to medical devic...