FDA Issues Guidance on Pediatric Drugs

FDA published two draft guidance documents on May 17, 2023 that provide recommendations to support pediatric drug approvals under the Pediatric Research Equity Act (PREA) and/or the Best Pharmaceuticals for Children Act (BPCA). The documents replace the draft guidance, How to Comply with the Pediatric Research Equity Act.

Pediatric Drug Development: Regulatory Considerations–Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act was written to assist sponsors in complying with pediatric study requirements under the PREA. It also describes how to qualify for pediatric exclusivity and protections under BPCA. Provisions in the BPCA were extended to biologics in 2010.

Pediatric Drug Development Under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act: Scientific Considerations helps sponsors develop data and information to support pediatric drug approvals. Selected clinical, scientific, and ethical issues are addressed.