1) Rationale for the change
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SOPP 8404.1: Procedures for Filing an Application When the Applicant Protests a Refusal to File Action (File Over Protest)
Version 2026-09-08
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- de48d5cac6e60b42c0ef4935c88d34c55524985c4f77192b553a9f36e74570e9
Change Summary
Imported from U.S. Food and Drug Administration source page.
Version Change Structure
2) To whom it applies
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4) The current change description
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