MLRagent

Rules

Aboutfair balancerisk disclosureindication on labelsubstantiationcomparativemisleading presentationname ingredientsubmissionpre approvalscientific exchangedisclosure
TrustAI-verifiedDisputedDraft
Severityblockerwarningnote
Decided bya checkhuman judgment
Naturepromotional
Basisconsistent-with-labelingunsolicited-requestunapproved-use-scientific
Audiencehcpconsumer
Document typeadvertisement
Risk info placementdistinct-part
Communication typeadvertisement
Mediumprintbroadcastdigitalsocialin-person
Regulatory classprescription-drug
Material typeprescription-drug-advertisementadvertisement
Launch stagepost-approvalpre-approval
Productdrugbiologicprescription-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 exemptionexcludes-reminder-adsexcludes-bulk-sale-drug-adsexcludes-prescription-compounding-drug-ads
Ad formattelevision
Intended specieshuman
Exemption statusnon-exempt
Approval pathwayaccelerated

12 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-009·21 CFR 202.1(b)(1)AI-verified
Established name sizing in detailed running-text columns, incl. larger-type proviso
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-011·21 CFR 202.1(b)(2)Disputed
Established-name lettering ≥ half size of featured proprietary name in Rx drug ads
blockerneeds human judgment
US-NAME-013·21 CFR 202.1(c)AI-verified
Place quantitative ingredient info with prominent proprietary name for unnamed drug mixtures
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-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-052·Section II.D.3AI-verified
Established name should accompany proprietary name at its most prominent web-page display
blockerneeds human judgment
US-NAME-053·Section II.D.2AI-verified
Audiovisual supers: established name should accompany prominent proprietary-name display
blockerneeds human judgment
US-NAME-054·21 CFR 201.10(g)(1) and 202.1(b)(1); Section II.D.2AI-verified
Established name must accompany proprietary name presentation in radio/telephone ads
blockerneeds human judgment