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
18 of 251 rules — including rules the source does not limit to any one scope
US-FB-002·21 CFR 202.1(e)(7)(vii)AI-verified
Repeated effectiveness claims in the risk section may dilute required side-effect emphasis
warningneeds human judgment
US-FB-003·21 CFR 202.1(e)(7)(viii)Disputed
Prescription-drug ad may lack fair balance if side-effect prominence trails efficacy
warningneeds human judgment
US-FB-004·21 CFR 202.1(e)(7)(ix)AI-verified
Facing pages must be clearly marked as one continuous advertisement
warningneeds human judgment
US-FB-005·21 CFR 202.1(e)(7)(x)AI-verified
Ads targeting a selected patient class may lack fair balance if class-specific risks/dosage are not adequately emphasized
warningneeds human judgment
US-FB-006·21 CFR 202.1(e)(7)(xi)Disputed
Multi-page Rx ads may lack fair balance if risk info isn't facing/full page
warningcheckable
US-FB-007·21 CFR 202.1(e)(7)(xii)AI-verified
Ad may be misleading if a page/spread lacks risk info or prominent locator reference
warningneeds human judgment
US-FB-009·Q.8/A.8, bullet 3AI-verified
Include related FDA-required labeling data for context when presenting related new information
warningneeds human judgment
US-FB-011·Section V, Recommendation 3AI-verified
Include representative publications reaching contrary conclusions when a source's conclusions are disputed
warningneeds human judgment
US-FB-012·Section III.B.1, QuantityDraft
Risk information should increase as benefit information increases
warningneeds human judgment
US-FB-013·Section III.B.1, QuantityAI-verified
Treat risk information comparably to benefit information throughout
warningneeds human judgment
US-FB-014·Section III.C.1, Overall Location of Risk InformationDisputed
Include risk information in the main part of the piece
warningneeds human judgment
US-FB-015·Section III.C.1, Overall Location of Risk InformationAI-verified
Present risk information in the same parts of the piece as benefits
warningneeds human judgment
US-FB-016·Section III.C.1, Overall Location of Risk InformationDisputed
Complete separation of benefit and risk information lacks appropriate prominence
warningneeds human judgment
US-FB-017·Section III.C, Considerations of FormatAI-verified
Make risk information comparably noticeable as benefit information
warningneeds human judgment
US-FB-018·Section III.C.1, Font Size and StyleAI-verified
FDA may object to substantially smaller font for risk information
warningneeds human judgment
US-FB-020·Section III.C.1, ContrastAI-verified
Do not give benefit information greater contrast than risk information
warningneeds human judgment
US-FB-021·Section III.C, Considerations of FormatAI-verified
Make risk information comparably readable as benefit information
warningneeds human judgment
US-FB-022·Section III.C.1, Font Size and StyleAI-verified
FDA may object to risk information in a difficult-to-read font size
warningneeds human judgment