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...
FDA posts a final guidance entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format Promotional Labeling and Advertising Mat...
Teleflex Medical recalls multiple models of the Hudson RCI Sheridan and Sheridan Endotracheal Tubes due to complaints about the devices connector disc...