Federal Register notice: FDA issues an order debarring Kris A. Hampton-Bey II for a period of five years from importing any drug into the U.S.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Dr. Reddys Xeglyze (abametapir).
Federal Register notice: FDA determines that Hikma Pharmaceuticals Reglan (metoclopramide injection, USP) was not withdrawn due to safety or effective...
Washington Legal Foundation says a California appeals court should reverse a trial court ruling holding Gilead liable for not developing a different H...
FDA approves three additional Centinel Spine cervical total disc replacement devices.
Rep. DeLauro and Sen. Durbin sponsor legislation to create a separate Food Safety Administration that would be responsible for all food programs now i...
FDA says the American Contract Systems recall of two test kits is Class 1.
FDA commissioner Robert Califf says his tenure at FDA will focus on improving evidence generation, which he described as being mediocre, and on tackli...