FDA and HHS Office for Human Research Protections issue a joint guidance on Institutional Review Board (IRB) Written Procedures; Guidance for Institut...
Alston Bird attorneys say the Court of Appeals for the Federal Circuit should reverse its decision in an Eli Lilly contributory patent infringement ca...
FDA publishes the names of drug companies it says may be blocking generic drug developers from obtaining needed samples.
Vermont becomes the first state to approve a law allowing U.S. drug wholesalers to import prescription drugs from Canadian drug wholesalers.
FDA backs away from awarding a sole source contract to a center run by former commissioner Mark McClellan,
FDA approves an Amneal Pharmaceuticals ANDA for a generic version of Daiichi Sankyos Welchol (colesevelam HCI) tablets, 625 mg.
Federal Register notice: FDA posts a final order to exempt certain surgical apparel from premarket notification requirements, subject to conditions an...
Healthcare experts offer a plan for comprehensive reform of the U.S. pharmaceutical system.