FDA Will Post Safety Reports On Recently Approved Drugs, Biologics

The Food and Drug Administration June 15 announced that it will post summaries of safety analyses for recently approved drugs and biologics on its website.

The summaries will be periodically prepared and posted on FDA’s website along with a brief discussion of the steps FDA is taking to address any identified safety issues, the agency said.

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, FDA said. The new summaries provide a comprehensive look at ...