1) Rationale for the change
Not specified for this version.
SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)
Version 2026-09-08
- Publication
- -
- Effective Date
- -
- Filename
- download
- Checksum
- f286ff040a1d51e9acd89a684c8cd296355aecf1f7180496c1f25cc54eec78df
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.
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