FDA Safety Analyses to Provide More Information Via Agency's Web site

June 23, 2010 3:47 PM

Aimed to provide additional information to both patients and health care providers, summaries of Food and Drug Administration (FDA) safety analyses on recently approved drugs and biologics will now be periodically posted on the FDA Web site. The new summaries will provide a comprehensive look at safety data early in the product’s post-approval life cycle, as reported in an FDA press release. Included in the summaries may be information on potentially serious, previously unidentified risks, if any are found during the review, as well as known adverse events that occur more often than they did during clinical studies. FDA notes that some side effects may not become apparent until after a medicine has been approved and becomes available to a larger, more diverse population than the patients who participated in clinical trials that supported approval. The summaries will also include a brief discussion of any steps FDA may be taking to address any identified safety issues.