FDA Launches Webpage with Summaries of Safety Data on New Drugs
On Tuesday, June 15, FDA launched a web page where you can find summaries of safety information about recently approved drugs and a brief discussion of any steps FDA may be taking to address any identified safety issues. New drugs approved after September 27, 2007 will receive a safety summary within roughly two years of approval. The summaries address safety risks that were not identified during a drug's development or prior to FDA approval. FDA plans to publish summaries on a quarterly basis.
The first set of safety summaries for 26 products approved in 2008 can be found here.
You can find questions and answers about FDA's plan to post safety summaries here.
Afia Asamoah, Transparency Initiative Coordinator