Give Kids a Chance Act of 2023

The Give Kids a Chance Act of 2023 amends FDA drug development rules to require new pediatric cancer studies for certain cancer drugs. It mandates that pharmaceutical companies conducting molecularly targeted cancer drug development must include pediatric studies designed to gather age-specific data on dosing, safety, and efficacy for drugs treating pediatric cancers. This applies to drugs with a single new active ingredient or combinations where each ingredient was previously approved for adult cancer treatment. The law requires FDA guidance within one year of enactment and includes reporting requirements to Congress on implementation progress and a GAO study on the policy's effectiveness. The changes apply to drug applications submitted three years after the bill's enactment.