Bill > S4215

This bill, the "Give Kids a Chance Act of 2022," aims to amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities for the Food and Drug Administration (FDA) regarding the conduct of pediatric investigations of molecularly targeted drugs to treat cancer. The key provisions of the bill include: 1) expanding the definition of a "molecularly targeted pediatric cancer investigation" to include drugs or biological products in combination with certain active ingredients; 2) requiring such investigations to be designed to yield clinically meaningful pediatric study data; 3) allowing the FDA to require preclinical studies for certain drug or biological product exemptions for investigational use to assist in determining the relevance of the molecular target to pediatric cancer; and 4) applying these changes to submissions and applications made on or after 2 years after the date of enactment.