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
14 of 251 rules
US-NAME-004·21 CFR 202.1(a)(3)AI-verified
No fanciful name implying unique effectiveness of a common substance
warningneeds human judgment
US-NAME-005·21 CFR 202.1(a)(4)AI-verified
Inert/inactive ingredients may not be featured to overstate their value
warningneeds human judgment
US-NAME-006·21 CFR 202.1(a)(5)AI-verified
No proprietary name confusable with another drug's name
warningneeds human judgment
US-NAME-012·21 CFR 202.1(b)(2)AI-verified
Established name must have prominence commensurate with the proprietary name
warningneeds human judgment
US-NAME-014·21 CFR 202.1(c)AI-verified
Quantitative ingredient info prominence must reasonably relate to proprietary name prominence
warningneeds human judgment
US-NAME-017·21 CFR 202.1(d)(2), read with 21 CFR 202.1(d)(1)AI-verified
Other dosage forms need quantitative info equal in prominence to name listing
warningneeds human judgment
US-NAME-021·Section II.AAI-verified
Established name should sit directly right of or below proprietary name
warningcheckable
US-NAME-022·Section II.AAI-verified
Avoid intervening matter that de-emphasizes or obscures the established name
warningneeds human judgment
US-NAME-033·Section II.D.1AI-verified
Print: established name once per page or spread when running text spans multiple pages
warningneeds human judgment
US-NAME-034·Section II.D.1AI-verified
Print: multi-column use of proprietary name allows established name once per page or spread
warningneeds human judgment
US-NAME-039·Section II.D.2AI-verified
Radio/telephone ads: established name conjoined with most prominent presentation suffices
warningneeds human judgment
US-NAME-040·Section II.D.3AI-verified
Digital: established name once per web page where proprietary name most prominent suffices
warningneeds human judgment
US-NAME-048·Section IIIAI-verified
Combination products: avoid intervening matter between proprietary name and active-ingredient information
warningneeds human judgment
US-NAME-050·Section IIIAI-verified
Combination products: active ingredients should get commensurate emphasis and contrast
warningneeds human judgment