Federal Register final rule: FDA classifies blood establishment computer software and accessories (regulated under product code MMH) into Class 2 (spe...
FDA issues a safety alert about serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies bo...
Federal Register notice: FDA announces a 6/14 Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee meeting t...
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,