1) Rationale for the change
Not specified for this version.
SOPP 8401.2: Administrative Processing of BLA and NDA Supplements
Version 2026-09-08
- Publication
- -
- Effective Date
- -
- Filename
- download
- Checksum
- c2598e079b287beca56296e286bb661f41ffcc7234ae326e6824f3d3227b22ee
Change Summary
Imported from U.S. Food and Drug Administration source page.
Version Change Structure
2) To whom it applies
Not specified for this version.
4) The current change description
Not specified for this version.
Newsletter
Get Guideline Updates in Your Mailbox
Subscribe for major GMP/GDP guideline changes, new publications and timeline updates.