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
10 of 251 rules — including rules the source does not limit to any one scope
US-FB-001·21 CFR 202.1(e)(5)(ii)AI-verified
Rx drug ad: effectiveness claims must be balanced by comparable risk information (502(n))
blockerneeds human judgment
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-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-017·Section III.C, Considerations of FormatAI-verified
Make risk information comparably noticeable as benefit 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