Bill > S2897

This bill, the Give Kids a Chance Act of 2023, amends the Federal Food, Drug, and Cosmetic Act to expand the requirements for molecularly targeted pediatric cancer investigations. Specifically, it allows for investigations of drugs or biological products in combination with certain approved cancer drugs that are the standard of care or targeting a molecular target relevant to pediatric cancers. The bill also requires certain design elements for these investigations to yield clinically meaningful data and limits the requirement for combination drug investigations. The Secretary of Health and Human Services is directed to issue guidance on implementing these changes and report to Congress on the implementation efforts. Additionally, the Government Accountability Office (GAO) is required to conduct a study and report on the effectiveness of these requirements in developing drugs and biological products for pediatric cancer indications.