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(Legal Document) FDA Publishes RACE for Children Act Draft Guidance for Industry

December 12, 2019

Addressing drug development for rare pediatric cancers, the newly released FDA draft guidance for industry calls for creating pediatric cohorts, embedding pediatric trials in adult trials, lowering the enrollment age for adolescents, conducting tissue-agnostic studies and master protocols.

FULL TEXT: FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs: Amendments to Sec. 505B of the FD&C Act.

The guidance has links to lists of relevant molecular targets for which pediatric studies are required, and those that are non-relevant to pediatric cancers.

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