1) Rationale for the change
Not specified for this version.
SOPP 8212: Breakthrough Therapy Products - Designation and Management
Version 2026-09-08
- Publication
- -
- Effective Date
- -
- Filename
- download
- Checksum
- d790f52a97ac504dd965930d6d259d174c89ad343dee2e7bec827e5c9a560f31
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.
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