Vivimed Life Sciences recalls 19 lots of losartan potassium tablets USP 25 mg, 50 mg, and 100 mg due to the detection of a known carcinogen N-nitroso...
The New York Times editorial board urges FDA to abolish the 510(k) medical device clearance process and fix other device regulatory loopholes amid gro...
Par Pharmaceutical recalls one lot of mycophenolate mofetil for injection after one product vial was observed containing a glass fragment after recons...
Federal Register notice: FDA announces the renewal of its Medical Imaging Drugs Advisory Committee for an additional two years beyond the charter expi...
FDA Review posts the Federal Register notices for the week ending 5/3/2019.
FDA Review post product approval summaries for the week ending 5/3/2019.
Federal Register notice: FDA announces the approval of product that redeemed a priority review voucher Alexion Pharmaceuticals Ultomiris (ravulizumab...
Federal Register notice: FDA has made available its annual compilation of updates to the Susceptibility Test Interpretive Criteria Web page.