FDA solicits feedback on its priority list of patient preference-sensitive areas intended to help the medical device industry and researchers.
FDA approves Medtronics CareLink SmartSync device manager that works through an Apple iPad.
Attorney Anne Walsh says a Justice Department guidance document on evaluating corporate compliance programs is similar to GMP requirements on drug and...
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...