Federal Register notice: FDA submits to OMB an information collection extension entitled Requirements on Content and Format of Labeling for Human Pres...
FDA accepts for priority review a Daiichi Sankyo NDA for quizartinib for treating adult patients with relapsed/refractory FLT3-ITD acute myeloid leuke...
FDA says Mylan has recalled 15 lots of valsartan-containing drugs that tested positive for NDEA above acceptable levels.
FDA grants OBI Pharma an Orphan Drug Designation for OBI-888 for treating pancreatic cancer.
The FDA Webview newsroom is closed in observance of the U.S. Thanksgiving Day holiday -- reopens Monday, November 26.
FDA approves an Elite Pharmaceuticals ANDA for a generic version of Norco (hydrocodone bitartrate and acetaminophen tablets).
FDA warns Surmasis Pharmaceutical about CGMP violations in its production of finished drugs.
FDA warns American Contract Systems about Quality System violations in its work as a medical device manufacturer and contract sterilizer.