1) Rationale for the change
Not specified for this version.
SOPP 8411.1: Administrative Handling and Review of Annual Reports for Approved Biologics License Applications (BLAs)
Version 2026-09-08
- Publication
- -
- Effective Date
- -
- Filename
- download
- Checksum
- 6ed61c3976f74e0862f4f7bd0b43586e6f66f21aae396d6d30abb33d87c479e0
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.