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REGULATORY-AFFAIRS5 MIN READ

Treat Every Deficiency as a Problem Statement

Convert an agency deficiency into a neutral problem statement before drafting the response.

The reframe: the deficiency is evidence about what the reviewer cannot yet see. Agency comments often sound like requests for documents, but many are really requests to close a reasoning gap. Treat the comment as a problem statement before treating it as a writing task. RCA keeps the team out of defense mode Root-cause analysis asks the team to define the problem, examine evidence, identify causes, and choose corrective action. In RA response work, the cause may be a data gap, a summary gap, a cross-reference gap, or a real technical gap. These are different problems and need different responses.…

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