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

3 of 251 rules

US-SCI-001·21 CFR 312.7(a)Disputed
Full Scientific Exchange About an Investigational Drug Is Not Restricted
noteneeds human judgment
US-SCI-012·Section V, Q3, item 2, Example 1AI-verified
Use a dedicated, separate exhibit-hall space for SIUU communications
noteneeds human judgment
US-SCI-026·Section V, Q4, item 2.a (CPGs)AI-verified
Shared CPG must be one that is revised as new evidence warrants
noteneeds human judgment