Bill > HR6972

This bill, the Give Kids a Chance Act of 2022, amends the Federal Food, Drug, and Cosmetic Act to expand the authority of the Food and Drug Administration (FDA) regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer. Specifically, it allows the FDA to require pediatric investigations of novel combinations of approved cancer drugs or drug candidates, and to require preclinical studies of certain cancer drugs to assist in determining their relevance for pediatric cancers. The bill also clarifies the applicability of certain provisions related to internal committee review, labeling changes, and adverse event reporting for these pediatric investigations.