The Justice Department says Amerisource Bergen is paying $625 million to resolve three whistleblower suits claiming that it operated a cancer supporti...
FDA releases its latest batch of Warning Letters that include Datascope Corp. and Sofie Biosciences.
FDA clears an Acessa Health 510(k) for the Acessa ProVu System, an integrated radiofrequency ablation, ultrasound visualization, and guidance mapping ...
Endo International recalls two lots of Robaxin (methocarbamol tablets, USP) 750mg tablets in 100-count bottle packs due to some products having incorr...
FDA says it has received reports of dosing errors and confusion with the labeled strength expression for certain compounded injectable products.
Federal Register notice: FDA releases a draft guidance entitled Contents of a Complete Submission for Threshold Analyses and Human Factors Submissions...
Federal Register notice: FDA makes available a draft guidance entitled Adaptive Designs for Clinical Trials of Drugs and Biologics.
Federal Register notice: FDA makes available a draft guide entitled Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Developme...