FDA clears a Helios Cardio 510(k) for CardiaMend Pericardial and Epicardial Reconstruction Matrix, indicated for both pericardial repair and reconstru...
Federal Register notice: FDA issues an order debarring William Kulakevich for five years from importing or offering for import any drug into the U.S.
FDA warns a clinical trial site in Ukraine that it failed to properly maintain required records.
FDA cautions Aspen Institute that it is illegally marketing cellular and exosome products to treat diseases and conditions in humans.
Epstein, Becker & Green attorney Bradley Thompson says there are differences between counties in the numbers of medical device inspections.
The Senate Health, Education, Labor & Pensions Committee delays a 1/5-scheduled confirmation vote on FDA commissioner nominee Robert Califf until 1/15...
Attorneys Jeffrey Gibbs and Gail Javitt say FDA contributed to the shortage of Covid-19 tests and call for a thorough, objective review of FDAs perfor...
FDA calls on isotretinoin manufacturers to propose a workable solution to issues with the iPLEDGE REMS Web site and telephone call center so treatment...