Federal Register notice: FDA makes available a final guidance entitled Considerations for the Conduct of Clinical Trials of Medical Products During Ma...
FDA grants Terumos MicroVention unit 510(k) clearance for its SOFIA EX 5F 115 cm intracranial support catheter for transradial access in addition to t...
FDA issues a complete response letter to an ARS Pharmaceuticals NDA for neffy, calling for a repeat-dose study.
FDA publishes a guidance to assist those involved with clinical trials in determining how to proceed during a disaster or public health emergency.
FDA commissioner Robert Califf tells a podcast that drug manufacturers have fought FDA efforts to encourage companies to produce more drugs when there...
FDA medical reviewers tell the Endocrinologic and Metabolic Drugs Advisory Committee that they believe the Intarcia NDA for its ITCA 650 drug/device c...
Two attorneys say their review of drug preemption cases shows that the defense is demanding but can be attained.
FDA grants Disc Medicine a fast-track designation for MWTX-003 and its use for treating patients with polycythemia vera.
