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
16 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-024·Section V, Q2AI-verified
Disclose that the unapproved use is unapproved and unestablished
warningcheckable
US-RISK-025·Section V, Q2AI-verified
Disclose labeling limitations, restrictions, cautions, warnings, or precautions about the unapproved use
warningcheckable
US-RISK-026·Section V, Q2AI-verified
Disclose contraindications from the FDA-required labeling
warningcheckable
US-RISK-027·Section V, Q2AI-verified
Disclose serious, life-threatening, or fatal risks relevant to the unapproved use
warningneeds human judgment
US-RISK-028·Section V, Q2AI-verified
Disclose an applicable REMS and its goals
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
US-RISK-034·Section III.C.1, Location of Risk Information within a Part of the Promotional PieceDisputed
Risk information should not appear only on a brief summary page
warningneeds human judgment