Federal Register notice: FDA issues a three-year debarment order against Poornanand Palaparty for receiving and distributing prescription oncology dru...
FDA commissioner Robert Califf and CBER director Peter Marks explain why biological therapies should be tested in randomized controlled trials.
Two professors call for updates to the FDA system for regulating drug promotion to account for new businesses that are promoting drugs through social ...
The CDRH 2022 annual report says the Center responded to many unique and important issues.
FDA says AstraZenecas Evusheld is no longer authorized for emergency use to fight Covid-19 infections.
Emergent recalls certain Reactive Skin Decontamination Lotion kits from a specific batch based on customer complaints about leakages.
The U.S. Justice Department charges 12 dental practice owners and co-conspirators with defrauding FDA, Medicaid, U.S. Immigration authorities, and the...
FDA tells Torrent Pharmaceuticals that a 9/2022 inspection of the companys India (Indrad, Gujarat) facility has been classified as Official Action Ind...