FDA to Post New On-line Information Regarding Safety Monitoring Issues for Recently-Approved Drugs and Biologics
This post was written by Paul Sheives.
FDA announced a new initiative, required under the Food and Drug Administration Amendments Act of 2007, to post summaries of FDA safety analyses and the agency’s plan to address them on the FDA website. Because evidence of some side effects arises following approval of the products, FDA is posting this information as a resource for consumers and health care professionals. The safety information posted on the website is pulled from reports to the FDA’s Adverse Event Reporting System and the Vaccine Adverse Event Reporting System, periodic safety reports by manufacturer, reports in the medical literature, and data from ongoing post-marketing studies. FDA will begin preparing summary reports for drugs and biologics approved since September, 2007.
