After several years of planning, FDA says it implementing its New Inspection Protocol Project to modernize inspections with a new way of assessing, re...
Sandoz recalls one lot of losartan potassium and hydrochlorothiazide after an impurity, NDEA (N-nitrosodiethylamine), was detected in the active pharm...
FDA approves a record number of generic drugs in October as part of its efforts to improve patient access to lower cost drugs.
On FDAs orders, U.S. marshals seize FDA-regulated products that the agency says were being held under insanitary conditions that exposed them to wides...
FDA approves a Theravance Biopharma and Mylan NDA for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with chronic...
Attorney Jeffrey Shapiro says FDA should seek congressional authority to continue to regulate some medical devices as drugs.
FDA has granted Korea-based Vivozon a fast track designation for VVZ-149, a non-opioid pain killer.
FDA says it is updating its Expanded Access Web pages and taking other steps to improve the program for patients and healthcare providers.