Bipartisan House members reintroduce the Promising Pathway Act that would provide a provisional approval pathway for promising drugs.
Federal Register notice: FDA announces an information collection revision entitled New Animal Drugs for Minor Use and Minor Species.
A Bloomberg editorial calls for better FDA regulation and more transparency in dealing with generic drugs and active pharmaceutical ingredients coming...
Federal Register notice: FDA makes available a final guidance entitled Chronic Rhinosinusitis With Nasal Polyps: Developing Drugs for Treatment.
Federal Register notice: FDA posts a list of eight information collections that have been approved by OMB.
LumiraDx files a 510(k) to gain clearance for its five-minute Covid Ultra Test and the LumiraDx Instrument.
FDA accepts the first master file for participation in the 510(k) Ethylene Oxide Sterility Change Master File Pilot Program.
In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 10.
