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REGULATORY-AFFAIRS5 MIN READ

Write an Agency Question That Can Be Answered

Draft a focused agency meeting question with decision context, sponsor position, and evidence options.

The team wants to ask, Do you agree with our development plan? The question is too broad to produce a useful agency answer. Premortem the failed meeting, then narrow with decision criteria The common trap is mistaking broadness for safety. A broad question feels comprehensive, but it lets the agency answer generally and leaves the sponsor without a clear decision. Premortem Imagine the meeting fails. Causes: question too broad, no sponsor position, no options, no evidence bridge, no requested agreement. The premortem turns vague anxiety into specific design risks in the briefing package. Decision Identify the decision that changes after…

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