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-NAME-007·21 CFR 202.1(b)(1)Disputed
Established name must accompany proprietary name each time featured in prescription drug ads
blockerneeds human judgment
US-NAME-008·21 CFR 202.1(b)(1)Disputed
Established name must appear with proprietary name in running text
blockerneeds human judgment
US-NAME-011·21 CFR 202.1(b)(2)Disputed
Established-name lettering ≥ half size of featured proprietary name in Rx drug ads
blockerneeds human judgment