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

30 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-002·21 CFR 202.1(a)(2)AI-verified
Ad ingredient order must match order on product label
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-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-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-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-012·21 CFR 202.1(b)(2)AI-verified
Established name must have prominence commensurate with the proprietary name
warningneeds 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-014·21 CFR 202.1(c)AI-verified
Quantitative ingredient info prominence must reasonably relate to proprietary name prominence
warningneeds 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-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-020·Section II.ADisputed
Trademark and controlled-substance symbols do not count as intervening matter
notecheckable
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-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-026·Section II.BDisputed
Type size is measured by actual letter height, not point size
notecheckable
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
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-041·21 CFR 201.10(g)(1) and 202.1(b)(1); Section II.D.3AI-verified
Digital: established name required once in running text when proprietary name not featured
blockercheckable
US-NAME-047·Section IIIDisputed
Combination products: active ingredients should be placed directly right of or below proprietary name
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
US-NAME-052·Section II.D.3AI-verified
Established name should accompany proprietary name at its most prominent web-page display
blockerneeds human judgment