FDA says the CDER Office of Prescription Drug Promotion will research how consumers and primary care physicians respond to drug ads containing informa...
FDA commissioner Robert Califf says the agency is being forced by artificial intelligence to rethink how it conducts business.
FDA warns Orange, CA-based neurologist Namita Goyal about violations found in a bioresearch monitoring inspection of a clinical trial she conducted.
FDA warns Phoenix, AZ-based Amnio Technology it is illegally manufacturing and distributing amniotic membrane and fluid products that have significant...
Otsuka reports positive topline interim data from an ongoing Phase 3 clinical trial of sibeprenlimab and its use for treating immunoglobulin A nephrop...
FDA sends Camurus a complete response letter on its NDA for CAM2029 (octreotide) extended-release injection and its use in treating patients with acro...
Federal Register notice: FDA extends the comment period for a 9/20 notice on a draft guidance entitled Chemical Analysis for Biocompatibility Assessme...
FDA publishes a draft guidance with recommendations for the placement and content of drug interaction information in labeling for human drugs and biol...
