Federal Register notice: FDA makes available a draft guidance entitled Decentralized Clinical Trials (DCT) for Drugs, Biological Products, and Devices...
Alleging weak evidence of effectiveness accepted by an advisory committee, Public Citizen calls on FDA to reject an Otsuka/Lundbeck sNDA for Rexulti t...
The Government Accountability Office says the National Institutes of Health should instruct its research and development grant awardees to name NIH an...
Xortx says a meeting with FDA staff provided the information needed to initiate a Phase 3 study of its Xorlo to treat autosomal dominant polycystic ki...
FDA adds three new tools to the Catalog of Regulatory Science Tools to Help Assess New Medical Devices and updates listings for five existing tools.
FDA commissioner Robert Califf tells a Senate HELP hearing that FDA inspection, diagnostic devices, and supply chain transparency reforms are needed.
FDA and the Duke-Margolis Center for Health Policy announce a 6/7-8 public workshop on the agencys Rare Disease Endpoint Advancement Pilot Program.
Federal Register notice: FDA announces a 6/15 advisory committee to select strain(s) to be included in the Covid19 vaccines for the 20232024 season.
