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
11 of 251 rules — including rules the source does not limit to any one scope
US-NAME-001·21 CFR 202.1(a)(1)AI-verified
Ingredient info block must be unbroken when 502(n) data is shown
blockercheckable
US-NAME-003·21 CFR 202.1(a)(2)AI-verified
Ingredient quantity in Rx drug ad must match product label
blockercheckable
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-010·21 CFR 202.1(b)(1)AI-verified
Relationship between proprietary and established name must be made clear
blockerneeds human judgment
US-NAME-015·21 CFR 202.1(d)(1)AI-verified
Listing of established names required with prominent display of shared combination name
blockerneeds human judgment
US-NAME-016·21 CFR 202.1(d)(2), first sentenceAI-verified
Combination-ingredient ads: dosage form name and adjacent 502(n) quantities
blockerneeds human judgment
US-NAME-024·21 CFR 201.10(g)(1) and (2) and 202.1(b)(1) and (2); Section II.BAI-verified
Established name must be at least half size when proprietary name is enlarged in running text
blockercheckable
US-NAME-025·21 CFR 201.10(g)(1) and (2) and 202.1(b)(1) and (2); Section II.BAI-verified
Established name outside running text must be at least half the proprietary name's size
blockercheckable
US-NAME-027·21 CFR 201.10(g)(2) and 202.1(b)(2); Section II.CAI-verified
Established name prominence must be commensurate with proprietary name prominence
blockerneeds human judgment
US-NAME-029·21 CFR 201.10(g)(1) and 202.1(b)(1); Section II.DAI-verified
Established name required once in running text when proprietary name is not featured
blockercheckable
US-NAME-030·21 CFR 201.10(g)(1) and 202.1(b)(1); Section II.DAI-verified
Established name required once per detailed-information column
blockercheckable