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

9 of 251 rules — including rules the source does not limit to any one scope

US-DISC-005·Section V, Q2Disputed
Provide a copy of or mechanism to obtain current FDA-required labeling
warningcheckable
US-DISC-009·Section V, Q2Disputed
State the publication date of referenced source publications
notecheckable
US-DISC-012·Section V, Q5Disputed
Firm-generated presentation itself should include Q2 disclosures
warningcheckable
US-DISC-013·Section V, Q5Disputed
Attribute safety/effectiveness conclusions to the source publication
warningcheckable
US-FB-006·21 CFR 202.1(e)(7)(xi)Disputed
Multi-page Rx ads may lack fair balance if risk info isn't facing/full page
warningcheckable
US-IND-014·Section V, Q2Disputed
Disclose the FDA-approved use(s) and labeling limitations
warningcheckable
US-NAME-020·Section II.ADisputed
Trademark and controlled-substance symbols do not count as intervening matter
notecheckable
US-NAME-026·Section II.BDisputed
Type size is measured by actual letter height, not point size
notecheckable
US-NAME-038·Section II.D.2Disputed
Audio portion of audiovisual/broadcast material need not include established name
notecheckable