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This meeting comes at a critical time for pediatric drug development. An accumulation of knowledge from pediatric drug development programs over the past 25 years provides information that should be used to improve the efficient development of safe and effective new drugs for children. At the same time, the reliance on juvenile animal testing for all pediatric preclinical assessments has run into both the realization of the limitations to this assessment plus the need to develop new approach methods (NAMs) to animal testing as expressed by the U.S. FDA and multiple federal agencies (see FDA-NIH Workshop on Reducing Animal Testing).

In addition, the recent ICH E11A Guidance on Pediatric Extrapolation has indicated that, under some conditions, safety can be extrapolated from the adult population to the pediatric patient population. Since developmental drug toxicity is not evaluable in the adult population, additional methods must be identified that can answer the critical developmental safety questions raised in the ICH E11A guidance.

Therefore, the goal of this workshop is to discuss new approach methods that can address pediatric developmental safety during drug development.

Learn more about the workshop here. 

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