Federal Register notice: FDA determines that the drug products listed in this notice were not withdrawn from sale for reasons of safety or effectivene...
Federal Register Notice: FDA has made available a draft guidance on Bacillus Calmette-Guerin (BCG) Unresponsive Nonmuscle Invasive Bladder Cancer: De...
FDA issues an updated guidance on 510(k) submissions for magnetic resonance diagnostic devices.
FDA appeals a DC district court decision that it acted arbitrarily and capriciously in denying Ferring five-year exclusivity for its Prepopik combinat...
Neos Therapeutics files an NDA for its Amphetamine XR oral suspension drug candidate, NT-0201, an attention-deficit hyperactivity disorder medication ...
Former FDA Office of Generic Drugs deputy director turned consultant Gordon Johnston, who pled guilty in June for being part of an insider trading sch...
The HHS inspector general describes three drug and medical device management and performance challenges facing FDA and the progress that has been made...
The Government Accountability Office says that some states and stakeholders say there have been challenges in FDAs implementation of the 2013 drug com...