FDAer Brooke Higgins discusses aseptic processing issues at a PDA/FDA joint regulatory conference.
FDA accepts for review a Samsung Bioepis sBLA for a high-concentration Humira biosimilar.
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...