FDA Has Improved Post-Market Drug Safety Program, Report Says

The Food and Drug Administration has improved its post-market drug safety program, according to a report released April 21 by the agency’s Center for Drug Evaluation and Research (CDER).

The report, Advances in FDA’s Safety Program for Marketed Drugs, describes new scientific tools and enhanced capabilities that give the same priority to post-market drug safety monitoring as to premarket drug review. The report also says CDER is delivering earlier, more effective drug safety information to the public to protect patients from harm.

In 2011, CDER issued 68 drug safety communications, up from 39 in 2010, the report said. The ...