Researchers say they found substantial misclassification of patient deaths in the FDA MAUDE medical device database.
FDA acting commissioner Ned Sharpless says the agency is working with Customs and Border Protection to identify potentially illicit vaping products co...
FDA grants Medtronic a breakthrough device designation for its Valiant TAAA Stent Graft System for repairing thoracoabdominal aortic aneurysms.
FDA approves Octapharmas Wilate (von Willebrand factor/coagulation factor VIII complex) for treating adults and adolescents with hemophilia A for rout...
FDA denies a Public Citizen petition seeking removal of products containing olmesartan medoxomil from the market for safety reasons.
Clarus asks FDA for written guidance on safety and efficacy standards needed for approval of an application for oral testosterone-ester prodrugs.
FDA issues Aurobindo a Form-483 after an inspection last month at the firms Unit 7 manufacturing facility in Telangana, India.
The Institute for Clinical and Economic Review identifies nine drugs whose 2017-2018 price increases were not supported by evidence of additional clin...