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
5 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-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-029·Section III.A.4, Hierarchy of Risk InformationDisputed
FDA recommends stating the most important risk information first, especially in print
warningneeds human judgment