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-RISK-002·21 CFR 202.1(e)(1)(i)(A)AI-verified
Broadcast ads must include the major statement in audio (or audio/visual)
blockercheckable
US-RISK-007·21 CFR 202.1(e)(1)(ii)(C)AI-verified
Television DTC ads must present major statement via concurrent audio and text
blockercheckable
US-RISK-008·21 CFR 202.1(e)(1)(ii)(C)(1)AI-verified
Television ads: on-screen major statement text must be verbatim key terms or full transcript
blockercheckable
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-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-023·Section VI, Recommendation 4AI-verified
Public response should include a mechanism to access current FDA-required labeling, if any
warningcheckable
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-028·Section V, Q2AI-verified
Disclose an applicable REMS and its goals
warningcheckable