Federal Register notice: FDA announces a 6/8 Antimicrobial Drugs Advisory Committee meeting to discuss an AstraZeneca BLA for nirsevimab, a long-actin...
Federal Register notice: FDA sends to OMB an information collection extension entitled Current Good Manufacturing Practice in Manufacturing, Packaging...
Pharmaceutical Research and Manufacturers of America tells FDA artificial intelligence offers many opportunities for manufacturers and supports the ag...
Two SheppardMullin attorneys say that drug manufacturers seeking accelerated approval should be aware that 10% of drugs approved through the pathway u...
FDA warns Elkhart, Indiana-based Voyant Beauty about CGMP and other violations in its work as a drug contract manufacturer.
FDA says a new draft guidance will help sponsors and investigators broaden and diversify clinical trial participation through using decentralized clin...
FDA awards DirectSync Surgical a breakthrough device designation for its patient-powered smart spinal fusion device.
Vanda asks the U.S. Court of Federal Claims to rule that FDA deliberately released confidential commercial information and trade secrets from two Vand...
