On September 29, 2010—just prior to the expert meeting—the FDA issued a new final rule and accompanying draft guidance concerning IND safety reporting. The requirements of the new safety rule, which went into effect on March 28, 2011, affected interpretation of the project findings described above. Meeting participants acknowledged that the new FDA rule marked a major step forward in recognizing that little knowledge can be gained from an individual event. Participants also agreed that inundating investigators with such data is inefficient and ineffective and that the FDA rule and guidance hold promise for helping to eliminate this burden on investigators. The discussion revealed, however, that implementation of the rule could pose challenges that may only be resolved through the concerted educational efforts and international harmonization of regulatory expectations.
*The views and opinions expressed in these presentations are those of the presenters and should not be attributed to the Clinical Trials Transformation Initiative, or any organization with which the presenters are employed or affiliated.