What remediation output looks like
For each identified risk, OPDP Intelligence provides specific, sourced suggestions tied to the claim or element in question — not generic advice.
Where more than one defensible path exists — for example, adding qualifying language versus narrowing the claim's scope versus adjusting risk-information prominence — multiple options are presented, because promotional review is rarely a single-right-answer exercise.
Option A
Add qualifying language to narrow the claim's scope.
Option B
Adjust risk-information prominence relative to the benefit claim.
Option C
Restructure the net impression created by the surrounding context.
Risk reduction, not a guarantee.
Remediation recommendations are designed to reduce regulatory risk. They do not guarantee FDA acceptance, and they are not a substitute for your organization's MLR, legal, or regulatory sign-off. The recommendation is an input to that process, not a stand-in for it.
See remediation guidance on a real asset.
Bring a flagged claim and see the sourced options OPDP Intelligence would surface.