Former FDA commissioner Robert Califf says the Novartis Zolgensma data integrity case shows the need for a well-funded and staffed FDA able to exercis...
FDA principal deputy commissioner Amy Abernathy tells the National Coordinator for Health IT Interoperability Forum about FDA current and planned acti...
Altaire Pharmaceuticals recalls several veterinary ophthalmic drug products due to concerns about quality assurance controls at its manufacturing faci...
An FDA inspection at the Alkem Laboratories Fenton, MO, drug manufacturing facility resulted in four inspection observations.
McDermott Will & Emery attorneys outline FDA efforts to modernize the drug regulatory review process.
The Bipartisan Policy Center, with three former FDA commissioners on its leadership team, issues a report with 12 recommendations for expanding use of...
Medline Industries recalls its Medline Primary Warmer Pack because it contains the recalled Becton Dickinson Alaris Infusion Sets for the Alaris Pump ...
Edwards Lifesciences recalls its Sapien 3 Ultra Delivery System due to balloon bursts during surgery.