Rules
Aboutfair balancerisk disclosureindication on labelsubstantiationcomparativemisleading presentationname ingredientsubmissionpre approvalscientific exchangedisclosure
Naturepromotional
Document typeadvertisement
Risk info placementdistinct-part
Communication typeadvertisement
Regulatory classprescription-drug
Drug classprescription
Rx statusprescription
Advertising typeprescription-drug-advertisement
Populationhuman-use
Content triggerliterature-or-study-effectiveness-claim
Materialadvertisement
Content typeadvertisement
Active ingredient counttwo-or-more
Proprietary name basismixture-designation
Established name statusnone-for-mixture-designation
Drug classificationprescription
Labeling scenariosingle-proprietary-name-multiple-preparations-no-established-name
Prescription statusprescription-drug
Ad formattelevision
Intended specieshuman
Exemption statusnon-exempt
Approval pathwayaccelerated
29 of 251 rules
US-MIS-016·21 CFR 202.1(e)(7)(ii)AI-verified
Statistical significance should not be used to imply unproven clinical significance
warningneeds human judgment
US-MIS-017·21 CFR 202.1(e)(7)(ii)AI-verified
Average results should disclose the range of variation
warningneeds human judgment
US-MIS-018·21 CFR 202.1(e)(7)(iii)AI-verified
Retrospective statistical mining to find unsupported findings may mislead
warningneeds human judgment
US-MIS-019·21 CFR 202.1(e)(7)(iii)AI-verified
Don't use retrospective stats to imply rigor for unsuited study designs
warningneeds human judgment
US-MIS-020·21 CFR 202.1(e)(7)(iv)AI-verified
Tables and graphs must not distort study relationships or trends
warningneeds human judgment
US-MIS-021·21 CFR 202.1(e)(7)(xiii)AI-verified
No falsely presenting reports/opinions as authentic or authoritative
warningneeds human judgment
US-MIS-022·Q.6/A.6AI-verified
Communications should not overstate study findings
warningneeds human judgment
US-MIS-023·Q.6/A.6AI-verified
Do not imply statistical rigor (e.g., via p-values) that the analysis lacks
warningneeds human judgment
US-MIS-024·Q.6/A.6AI-verified
Disclosing limitations does not cure a claim based on an inadequate study
warningneeds human judgment
US-MIS-026·Section V, Recommendation 3AI-verified
Response should include complete reprints and literature, not just firm summaries
warningcheckable
US-MIS-027·Section V, Recommendation 4AI-verified
Keep unsolicited-request response material scientific in tone, not promotional
warningneeds human judgment
US-MIS-028·Section V, Recommendation 4AI-verified
Do not bundle the off-label response with promotional material
warningneeds human judgment
US-MIS-029·Section VI, Recommendation 4AI-verified
Public responses should not be promotional in nature or tone
warningneeds human judgment
US-MIS-036·Section V, Q5 (prohibited practices)AI-verified
Do not imply the source data represents broader experience than it does
warningneeds human judgment
US-MIS-041·Section II.B, Policy OverviewAI-verified
A deceptive net impression can be misleading even when individual claims are not
warningneeds human judgment
US-MIS-042·Section III.A.1, Consistent Use of LanguageAI-verified
Use risk language comprehensible to the same audience as benefit language
warningneeds human judgment
US-MIS-043·Section III.A.2, Use of SignalsAI-verified
Use headlines/signals for risk information whenever benefit information is signaled
warningneeds human judgment
US-MIS-044·Section III.A.2, Use of SignalsDisputed
Risk information should be preceded by a signal indicating risk information follows
warningneeds human judgment
US-MIS-045·Section III.A.3, Framing Risk InformationAI-verified
Match specificity of risk statements to benefit statements
warningneeds human judgment
US-MIS-046·Section III.A.3, Framing Risk InformationAI-verified
Risk wording should not minimize the severity of a risk event
warningneeds human judgment
US-MIS-047·Section III.A.4, Hierarchy of Risk InformationAI-verified
Risk ordering should not falsely suggest a risk applies only to certain populations or conditions
warningneeds human judgment
US-MIS-048·Section III.C.2, Non-Print Promotion, Textual ElementsAI-verified
Vocalize, visualize, or place concurrent SUPERs for required claim qualifiers
warningneeds human judgment
US-MIS-049·Section III.C.2, Non-Print Promotion, Textual ElementsDraft
Qualifying SUPERs should appear close enough to the claim they qualify
warningneeds human judgment
US-MIS-051·Section III.C.2, Non-Print Promotion, Textual ElementsAI-verified
Make SUPERs reasonably visible under typical viewing conditions
warningneeds human judgment
US-MIS-052·Section III.C.2, Non-Print Promotion, Textual ElementsAI-verified
SUPERs should remain on screen long enough to be read and understood
warningneeds human judgment
US-MIS-053·Section III.C.2, Non-Print Promotion, Textual ElementsAI-verified
Distracting graphics during risk presentations should be avoided
warningneeds human judgment
US-MIS-054·Section III.C.2, Non-Print Promotion, Textual ElementsDraft
Risk-related SUPERs should not compete with unrelated SUPERs on screen
warningneeds human judgment
US-MIS-056·Q.6/A.6AI-verified
Material study limitations should be disclosed
warningneeds human judgment
US-MIS-057·Section III.A.2, Use of SignalsAI-verified
A risk-information presentation should not open with unrelated content
warningneeds human judgment