Federal Register notice: FDA reopens the comment period regarding issues related to utilizing the product identifier for product tracing and improving...
Federal Register notice: FDA determines that a list of drug products were not withdrawn from sale for reasons of safety or effectiveness to make it ea...
FDA issues an FDA-483 to Dr. Reddys Laboratories with 11 inspection observations for the companys formulation manufacturing plant at Bachupally, Hyder...
FDA warns Indias Sal Pharma about CGMP deviations and misbranding of active pharmaceutical ingredients.
FDA warns Unetixs Vascular about Quality System violations in its manufacturing of vascular diagnostic ultrasound systems.
The Esophageal Cancer Action Network asks FDA to order stronger cancer-risk warnings for OTC products labeled to relieve or prevent heartburn associat...
FDA and NIH issue a finalized template for clinical trial protocols.
Medtronic attorney Max Heerman says company representatives provide valuable assistance in operating rooms and should continue to be welcomed there wi...