FDA updates a 2018 safety alert about Endologixs AFX endovascular graft systems used in treating abdominal aortic aneurysms and the risks associated w...
Federal Register notice: FDA announces an 11/21 public meeting seeking input on a report to Congress about pediatric study requirements.
Federal Register notice: FDA seeks comments on an information collection extension entitled Planning for the Effects of High Absenteeism To Ensure Ava...
FDA posts a draft guidance on Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software.
FDA releases a fact sheet to explain its Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program: Draft Guidance.
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...