FDA Pediatric Research Equity Act

The FDA Pediatric Research Equity Act (PREA) requires drug and biologic companies to study their products in children when the medication could be used for pediatric patients. This ensures that treatments are safe and effective for children, not just adults. PREA encourages developers to include pediatric information early in the research process, helping doctors make informed decisions about prescribing medications to younger patients. Essentially, it promotes the development of appropriate dosing and safety data tailored to children, addressing a previous gap in medical knowledge where many medicines lacked research for pediatric use.