A Fresh Perspective from the FDA on the Final IND Safety Reporting Rule

June 9, 2021

In this webinar, Robert Temple, the Deputy Director of CDER and Jacqueline Corrigan-Curay, the Director of the Office of Medical Policy will join us to discuss how chronic over-reporting of SUSARs to investigators and ethics committees has risen to a critical level in affecting patient safety and what to do about it.

10 years ago, the FDA issued the Final IND Safety Reporting Rule. This highly anticipated guidance was expected to fix all the major problems with sponsors and investigators experience of IND safety reporting. Instead, in 2021, the problems for sites, particularly oncology sites, are greater than ever. Rather than the expected 90% reduction in IND safety reports that the FDA anticipated, the FDA and sites continue to receive more and more IND safety reports every year. What has gone wrong?

In this webinar, we’ll address this topics and questions such as:

  • Why do the FDA, investigators and IRBs continue to receive large numbers of uninformative safety reports that do not comply with the final IND safety reporting rule?
  • What are the regulatory consequences for sponsors who continue to report serious adverse events that are manifestations of the underlying disease and commonly occur in the study population?
  • How can Safety Assessment Committees resolve some of the current problems sponsors face with complying with the final rule?
  • How do we resolve problems between sponsors and leading academic site networks who are refusing to process expedited safety reports that do not comply with the final rule?
  • What is the FDA doing to harmonize its scientifically optimal IND safety reporting approach with the more conservative over-reporting approaches adopted by other countries?
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