Assess post-approval change risk before recommending a regulatory pathway.
Manufacturing proposes extending intermediate hold time from 24 to 36 hours for an approved product. The team wants RA to confirm whether the change is minor before supportive data are complete. Severity, probability, detectability, then pathway The common trap is starting with the desired filing category. Once the team says minor, every discussion bends toward defending that label, even if the evidence for product-quality impact is not mature. Define State the change precisely: intermediate hold time increases from 24 to 36 hours at a named process step under the same storage condition. Precise change definition prevents the team from hiding…
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