FDA warns the Telangana, India-based Natco Pharma manufacturing facility about CGMP violations in its production of finished drugs.
CDER establishes the Center for Clinical Trial Innovation to support innovative approaches to clinical trials that are designed to improve the quality...
A federal court sentences former Decision Diagnostics CEO Keith Berman to seven years in prison for a securities fraud scheme involving a Covid-detect...
FDA issues a safety alert on unsafe counterfeit versions of AbbVies Botox (botulinum toxin) have been found in multiple states and administered to con...
FDA approves an Xstim PMA for the Xstim Spine Fusion Stimulator for bone growth stimulation.
FDA adds CBER to its partnership with the Lupus Accelerating Breakthroughs Consortium to better focus on engineered cell therapies.
FDA warns South Koreas C&T Dream Co. about CGMP violations in its manufacturing of finished drugs.
FDA launches a new public dataset to help chemistry labs ensure the robustness of chemical characterization methods used to assess the biocompatibilit...
