Benefits must outweigh risk...this is the cornerstone of patient safety.
Resources
FDA, Drug Safety and Availability
This page provides links to the overall drug safety information.
FDA, Postmarket Requirements and Commitments
This is a searchable database of requirements after a drug has been approved.
FDA, Newly Added Guidance Documents
This page provides the latest guidance documents for three months.
The latest listing of drugs with their application number and links.
Federal Register, March 27, 2008
This page provides a list of products deemed to have in effect an approved REMS as stated by Food and Drug Administration Amendments Act of 2007 (FDAAA) by March 25, 2008.