1) Rationale for the change
Not specified for this version.
SOPP 8421: Complying with Requirements under the Pediatric Research Equity Act (PREA) & Best Pharmaceuticals for Children Act (BPCA)
Version 2026-09-08
- Publication
- -
- Effective Date
- -
- Filename
- download
- Checksum
- e420afdeeb85b08a0ab32bc9de9327f70bf51854f5fbc9bb74193f2c0dfe9b2c
Change Summary
Imported from U.S. Food and Drug Administration source page.
Version Change Summary
2) To whom it applies
Not specified for this version.
4) The current change description
Not specified for this version.
Newsletter Sign-up
Get Guideline Updates in Your Inbox
Subscribe for major GMP/GDP guideline changes, new publications and timeline updates.