[ Price : $8.95]
FDA publishes a guidance describing its use of some alternative tools in specified drug facility inspections.[ Price : $8.95]
CBER sends an untitled letter to AstraZeneca citing the firm for running a misleading television direct-to-consumer advertisement ...[ Price : $8.95]
Philips Respironics recalls (Class 1) certain DreamStation auto continuous positive airway pressure and auto bilevel positive airw...[ Price : $8.95]
FDA commissioner Martin Makary pens an online JAMA Viewpoint to explain why the agency is moving to rein in direct-to-consumer pha...[ Price : $8.95]
CBER hosts a 10/22 virtual town hall focused on gene therapy manufacturing requirements for BLAs and post-licensure changes.[ Price : $8.95]
FDA under President Donald Trump advances plans discussed during the Biden Administration to scale back its long-standing practice...[ Price : $8.95]
Intercept Pharmaceuticals withdraws Ocaliva (obeticholic acid) from the U.S. market for treating primary biliary cholangitis, foll...[ Price : $8.95]
A USC Schaeffer Center for Health Policy and Economics white paper urges FDA to take several steps it says can modernize drug deve...