Sen. Bill Cassidy says FDA needs to explain why it ignored Congress and expanded its oversight over clinical decision support software.
Fresenius Kabi USA recalls its Ivenix Infusion Systems pump software due to a necessary software update.
Eli Lilly plans to file an NDA mid-year for tirzepatide and its use in treating obstructive sleep apnea; the drug is currently marketed as Zepbound fo...
Novartis asks FDA to impose limits on applications for generic forms of its Lutathera radioligand.
FDA issues Sun Pharmaceutical Industries a six-item Form-483 following a two-week December inspection at the firms Dadra, Dadra & Nagar Haveli and Dam...
FDA warns Soulaire Corp. that it is marketing an external counterpulsation system for unapproved uses, adulterating and misbranding the unit.
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...
