1) Rationale for the change
Not specified for this version.
SOPP 8401.4: Review Responsibilities for the CMC Section of Biologic License Applications, New Drug Applications and Supplements
Version 2026-09-08
- Publication
- -
- Effective Date
- -
- Filename
- download
- Checksum
- 0c1a8ec668c04533b6f8bfa60ba2915bc4db44ceba2bd4c2f4feddf0b1254756
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
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