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
15 of 251 rules — including rules the source does not limit to any one scope
US-RISK-001·21 CFR 202.1(e)(1)-(3)Disputed
Prescription drug ads need true brief summary, with broadcast alternative
blockerneeds human judgment
US-RISK-012·21 CFR 202.1(e)(2)(i)AI-verified
Reminder ads are limited to specified content only
blockerneeds human judgment
US-RISK-013·21 CFR 202.1(e)(2)(i)AI-verified
Reminder ads are not permitted for drugs with a boxed warning
blockercheckable
US-RISK-014·21 CFR 202.1(e)(3)(iii)AI-verified
Each specific side effect and contraindication in labeling must be disclosed
blockerneeds human judgment
US-RISK-015·21 CFR 202.1(e)(3)(iii)AI-verified
Grouped side-effect terms allowed only if previously approved for that use
warningneeds human judgment
US-RISK-016·21 CFR 202.1(e)(5)(i)AI-verified
An ad fails the true-statement test if false or misleading on safety/effectiveness
blockerneeds human judgment
US-RISK-017·21 CFR 202.1(e)(6)(xx)AI-verified
General group terms may not replace required specific side-effect disclosure
blockerneeds human judgment
US-RISK-019·Section V, Recommendation 2 (exception)AI-verified
Disclose relevant risk information beyond the narrow scope of the request when material
warningneeds human judgment
US-RISK-020·Section V, Recommendation 6 (A copy of the FDA-required labeling bullet)Disputed
Accompany unsolicited-request response with FDA-required labeling, if any
warningcheckable
US-RISK-021·Section V, Recommendation 6 (A prominent statement notifying … bullet)Disputed
State prominently that FDA has not approved or cleared the discussed use
warningneeds human judgment
US-RISK-022·Section V, Recommendation 6 (A prominent statement providing … bullet)Disputed
Include prominent statement of all important safety information, including any boxed warning
warningneeds human judgment
US-RISK-023·Section VI, Recommendation 4AI-verified
Public response should include a mechanism to access current FDA-required labeling, if any
warningcheckable
US-RISK-029·Section III.A.4, Hierarchy of Risk InformationDisputed
FDA recommends stating the most important risk information first, especially in print
warningneeds human judgment
US-RISK-030·Section III.A.4, Hierarchy of Risk InformationAI-verified
Risk information should not be presented in only one location of the piece
warningneeds human judgment
US-RISK-033·Section III.B.2, The Nature of Benefit ClaimsAI-verified
Promotional pieces should reveal risks material to the specific benefit claims made
warningneeds human judgment