FDA warns Switzerlands Lonza Group about Quality System violations in its contract manufacturing of Class 2 medical devices.
The Tufts Center for the Study of Drug Development says it expects the approval rate of biotech products over the 2000-16 period of 10 to 20 approvals...
CDRH says it is establishing a centralized digital health unit within the Office of the Center Director to ensure proper coordination and consistency ...
FDA grants Oncolytics Biotech a fast track designation for Reolysin, an immuno-oncology viral agent for treating metastatic breast cancer.
FDA clears a Medrobotics 510(k) for the Flex Robotic System and its use for colorectal procedures.
FDA sends TherapeuticsMD a complete response letter on its NDA for TX-004HR, an investigational applicator-free estradiol vaginal softgel capsule for ...
FDA clears a CurveBeam 510(k) for InReach, a cone beam computed tomography imaging system designed for the hand, wrist, elbow and lower extremities in...
U.S. Senators Michael Bennet (D-CO), Orrin Hatch (R-UT), Richard Burr (R-NC), and Bob Casey (D-PA) introduce legislation to improve clinical trials fo...