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

US-RISK-002·21 CFR 202.1(e)(1)(i)(A)AI-verified
Broadcast ads must include the major statement in audio (or audio/visual)
blockercheckable
US-RISK-003·21 CFR 202.1(e)(1)(i)(B)AI-verified
Broadcast ads need a brief summary or adequate provision for labeling access
blockerneeds human judgment
US-RISK-007·21 CFR 202.1(e)(1)(ii)(C)AI-verified
Television DTC ads must present major statement via concurrent audio and text
blockercheckable
US-RISK-008·21 CFR 202.1(e)(1)(ii)(C)(1)AI-verified
Television ads: on-screen major statement text must be verbatim key terms or full transcript
blockercheckable
US-RISK-012·21 CFR 202.1(e)(2)(i)AI-verified
Reminder ads are limited to specified content only
blockerneeds human judgment
US-RISK-013·21 CFR 202.1(e)(2)(i)AI-verified
Reminder ads are not permitted for drugs with a boxed warning
blockercheckable
US-RISK-014·21 CFR 202.1(e)(3)(iii)AI-verified
Each specific side effect and contraindication in labeling must be disclosed
blockerneeds human judgment
US-RISK-016·21 CFR 202.1(e)(5)(i)AI-verified
An ad fails the true-statement test if false or misleading on safety/effectiveness
blockerneeds human judgment
US-RISK-017·21 CFR 202.1(e)(6)(xx)AI-verified
General group terms may not replace required specific side-effect disclosure
blockerneeds human judgment