Federal Register notice: FDA reopens the comment period for the 4/4 notice entitled In-Home Disposal Systems for Opioid Analgesics; Request for Inform...
In an unusual move, FDA issues a statement about recent agency inspections at Novo Nordisks Clayton, NC manufacturing facility to quell concerns about...
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...
