
FDA Issues Guidance on Pediatric Drugs
The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.
FDA published two draft guidance documents on May 17, 2023 that provide recommendations to support pediatric drug approvals under the Pediatric Research Equity Act (PREA) and/or the Best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 The documents replace the draft guidance, How to Comply with the Pediatric Research Equity Act.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:
Source: FDA
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