Which act provided FDA authority to require pediatric studies of drugs?

The Pediatric Research Equity Act (PREA) is the act that specifically granted the FDA the authority to require drug manufacturers to conduct pediatric studies for new drug applications and specific supplemental applications. This legislation aims to ensure that drugs are properly tested for safety and efficacy in children, addressing the historical lack of pediatric data for many medications.

PREA was enacted in response to concerns that medications often used in children were not adequately evaluated for this population, leading to potential safety risks and ineffectiveness. By empowering the FDA to request studies, PREA plays a crucial role in ensuring that pharmaceutical products are appropriately labeled for pediatric use and that the unique physiological differences in children are taken into consideration during drug development.

The other acts listed do not specifically focus on pediatric studies. The Hatch-Waxman Act primarily deals with drug patenting and market exclusivity. The Orphan Drug Act encourages the development of treatments for rare diseases without a direct emphasis on pediatrics. The FDA Amendments Act reinforces the FDA's authority to regulate drug safety but does not specifically mention pediatric studies as a requirement.