FDA says three of four problem scenarios described by Becton Dickinson in its recall of Alaris infusion pumps are Class 1.
President Trump says drug company executives are coming to see him this week and he expects a major cut in prescription drug prices.
Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Innate Pharmas Lumoxiti.
Federal Register notice: FDA seeks comments on an information collection extension for Adverse Experience Reporting For Licensed Biological Products; ...
FDA warns Mylan about CGMP deviations in producing active pharmaceutical ingredients at one of its facilities in India.
FDA warns Acella Pharmaceuticals about CGMP and other violations in its production of finished drugs.
Two drug company stakeholders respond to an FDA draft guidance on Orange Book questions and answers.
Attorney Jeffrey Shapiro discusses reasons why HHS made the right decision in ordering FDA to abstain from the premarket review of laboratory-develope...