FDA accepts for review a Heron Therapeutics NDA resubmission for HTX-011, an investigational agent for managing postoperative pain.
Allergan and its Forest Laboratories subsidiaries agree to pay $750 million to settle a lawsuit brought by direct purchasers of Alzheimer drug Namenda...
Federal Register notice: FDA sends to OMB an information collection extension entitled Administrative Procedures for Clinical Laboratory Improvement A...
FDA Review posts the Federal Register notices for the week ending 10/25/2019.
Federal Register notice: FDA classifies orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into Class 2 (...
Federal Register notice: FDA makes available a revised draft guidance entitled Drug Products Labeled as Homeopathic.
Federal Register notice: FDA withdraws the NDA approval of Allergan Pharmaceuticals Lo Minastrin FE because it is no longer marketed.