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RACE for Children Act: Product Development Considerations




In August 2020, the RACE for Children Act will go into effect. Until now, certain treatments, such as cancer drugs with orphan designation, were exempt under the Pediatric Research Equity Act (PREA). The RACE for Children Act eliminates the orphan exemption for new cancer drugs directed at molecular targets relevant to children’s cancers.

Complying with the RACE for Children Act and PREA

With the RACE for Children Act, any original new drug application (NDA) or biologics licence application (BLA) submitted on or after 18 August 2020, for a new active ingredient to treat an adult cancer indication with orphan designation, must have an agreed paediatric study plan (PSP) in place (even if the adult indication does not occur in children) if the molecular target is substantially relevant to the growth or progression of a paediatric cancer. More drug developers will now need to consider the implications of PREA. In December 2019, the FDA issued a draft guidance to help companies comply with the new regulations (1).

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About the author


Lynne Georgopoulos, RN, MSHS, RAC, is Vice President of Regulatory Affairs and Pediatric Strategic Development at Synteract. She is responsible for providing professional leadership to ensure compliance with FDA, EMA, and ICH regulations in the creation and execution of preclinical, clinical, and regulatory strategies to support paediatric drug development across multiple therapeutic areas. She draws on 30- plus years in clinical operations/development, regulatory affairs, project management, and quality assurance with extensive R&D experience in small molecules and protein therapeutics, from investigational NDA to NDA/BLA.
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