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# Pediatric Research Policy and Procedure
- URL: https://www.fdaweb.com/pediatric-research-policy-and-procedure/
- Published: 2026-09-02T12:00:00.000Z
- Updated: 2026-09-14T12:05:21.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161720

CBER has published a Standard Operating Policy and Procedure (SOPP), *Complying with Requirements Under the Pediatric Research Equity Act (PREA) & Best Pharmaceuticals for Children Act (BPCA)*, as a resource to ensure that sponsors/applicants and CBER staff follow the required procedures and timeframes under the two laws. The [SOPP](https://www.fda.gov/media/160734/download?attachment&ref=fdaweb.com) applies to INDs, NDAs, and BLAs and related supplements for a new active ingredient, new indication, new dosage form, new dosing regimen, or new route of administration.

“This SOPP does not repeal existing PREA & BPCA related resources for CBER staff,” the document says, “but rather provides general information and expectations on how CBER and sponsors/applicants will comply with PREA & BPCA.”