The Food and Drug Administration is poised to publish a proposed rule to require notification from drug manufacturers of discontinuances or interruptions in the manufacturing of life-supporting and certain other important drugs.
The rule, sent to the Office of Management and Budget for final review before publication, is authorized under the Food and Drug Administration Safety and Innovation Act of 2012. Early notification of issues that could lead to shortages helped FDA prevent more than 100 shortages during 2012, according to the agency.
Register or login for access to this item and much more
All Health Data Management content is archived after seven days.
Community members receive:
- All recent and archived articles
- Conference offers and updates
- A full menu of enewsletter options
- Web seminars, white papers, ebooks
Already have an account? Log In
Don't have an account? Register for Free Unlimited Access