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SOPP 8421: Complying with Requirements under the Pediatric Research Equity Act (PREA) & Best Pharmaceuticals for Children Act (BPCA)

Imported from U.S. Food and Drug Administration (http://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-procedures-sopps).

Organizations:
FDA

Version Timeline

Chronological release history

2026-09-21

Version milestone

en

Publication Date

Sep 21, 2026

Effective Date

Not specified