Former FDA principal deputy commissioner Joshua Sharfstein calls for reforms to the agencys decades of drug regulation reform to increase the effectiv...
FDA grants ArcherDX a breakthrough device designation for its Personalized Cancer Monitoring technology for early-stage cancer treatment monitoring an...
House Energy and Commerce Committee Republican leaders say they are renewing a 2018 investigation into three opioid manufacturers to get all the infor...
A new FDA safety alert says that results from a clinical trial assessing safety of Eisais weight-loss drugs Belviq and Belviq XR (lorcaserin) show a p...
FDA places a partial clinical hold on Innate Pharmas TELLOMAK Phase 2 trial that is evaluating lacutamabs efficacy and safety in patients with advance...
CDER director Janet Woodcock says enhancing postmarket safety initiatives and modernizing the Centers new drugs regulatory program are two of the top ...
Federal Register notice: FDA exempts powered wheeled stretchers from premarket notification (510(k)) requirements.
Federal Register notice: FDA makes available a draft guidance entitled Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters ...