Shortage Reporting Should Be Over-Inclusive, FDA Tells Drugmakers
Executive Summary
Draft guidance urges manufacturers to err on the side of over-reporting when it comes to vital drugs that may be going into shortage.
You may also be interested in...
Drug Shortages Endgame: FDA Goes On Offensive As Legislative Plot Thickens
FDA press conference on alleviating shortages shows how the agency works with industry to advance legislation that firms may not be particularly fond of themselves. But the agency still seems to face an uphill legislative battle.
FDA’s Drug Shortage Reg Adds More Manufacturers, Products To Notification List
Interim final rule redefines the terms “sole manufacturer” and “discontinuance.”
Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says
Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.