FDA says it wont ban textured breast implants but is taking steps to improve risk communication with women and healthcare providers and to improve fut...
The American Dental Association asks FDA to take legal action against SmileDirectClub for essentially selling prescription teeth aligners and dental i...
Delivering the annual FDLI keynote address, FDA acting commissioner Ned Sharpless vows to heed the advice of previous commissioners he consulted: to l...
FDA approves an Agios Pharmaceuticals supplemental NDA to update the U.S. prescribing information for Tibsovo to include adult patients with newly dia...
Federal Register notice: FDA announces a 6/5 public meeting entitled International Cooperation on Cosmetics Regulation (ICCR) Preparation for ICCR-13...
FDA approves a Sanofi Pasteur BLA for Dengvaxia, the first vaccine approved for preventing dengue disease caused by all dengue virus serotypes.
Eight public health advocacy organizations urge FDA to continue to work for passage of legislation to reform the OTC drug monograph system.
CDRH says it is implementing a reorganization centered on a new Office of Product Evaluation and Quality that has been in a one-year pilot program.