FDA approves a Stryker PMA for the Surpass Streamline Flow Diverter to treat unruptured large and giant wide neck intracranial aneurysms.
FDA says several companies have recalled their valsartan-containing drug products, which are used to treat high blood pressure and heart failure, due ...
A federal court sentences Kristjan Thorkelson (Manitoba, Canada) and several associated Canadian companies to forfeit $29 million in illegal proceeds ...
FDA Review posts the Federal Register notices for the week ending 7/13/2018.
Federal Register notice: FDA makes available a draft guidance entitled Long Term Follow-Up After Administration of Human Gene Therapy Products.
Federal Register notice: FDA makes available a draft guidance entitled Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication ...
FDA releases a 32-page FDA-483 with 11 observations from an inspection at Hospira Healthcare India.