NCCS joined the Alliance for Childhood Cancer in submitting comments to the Food and Drug Administration (FDA) following the January 2014 public workshop on complex issues in developing drug and biological products for rare diseases. The Alliance encouraged the FDA to consider the issues specific to pediatric cancers that may be different from other rare disease and to continue to adopt a flexible approach to risk-benefit assessment for pediatric cancer drug development. Additionally, the Alliance urged the FDA to establish clinical trial endpoints that reflect quality of life concerns.
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