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
3 of 251 rules
US-MIS-002·21 CFR 202.1(e)(3)(i)Disputed
Misleading omissions in prescription drug ads require added qualification within that part/theme
blockerneeds human judgment
US-MIS-013·21 CFR 202.1(e)(6)(xiv)Disputed
No misleading pooled statistics in prescription drug advertising
blockerneeds human judgment
US-MIS-044·Section III.A.2, Use of SignalsDisputed
Risk information should be preceded by a signal indicating risk information follows
warningneeds human judgment