by selected recommendations from the report, and are summarized here in seven key areas:

  • addressing the FDA’s resource challenges;

  • strengthening the scientific base of the agency;

  • integrating pre- and postmarket review;

  • enhancing postmarket safety monitoring;

  • conducting confirmatory drug safety and efficacy studies;

  • enhancing the value of clinical trial registration; and

  • enhancing the FDA’s postmarket regulation and enforcement.

The presentations and discussions included the types and magnitude of resources required in these areas. A session at the close of the symposium looked to the future, exploring prerequisites for revitalizing the U.S. drug safety system and the future of drug safety regulation. It should be noted that, while the IOM report suggested some organizational and cultural changes at the FDA, those recommendations were not a focus of the discussions during the symposium. Additionally, participants did not deliberate upon whether the FDA in its current form is properly configured to lead the efforts that were discussed.



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