Rules
Aboutfair balancerisk disclosureindication on labelsubstantiationcomparativemisleading presentationname ingredientsubmissionpre approvalscientific exchangedisclosure
Naturepromotional
Document typeadvertisement
Risk info placementdistinct-part
Communication typeadvertisement
Regulatory classprescription-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 formattelevision
Intended specieshuman
Exemption statusnon-exempt
Approval pathwayaccelerated
15 of 251 rules
US-DISC-001·Q.8/A.8, bullet 1AI-verified
Accurately represent study results relied upon
warningneeds human judgment
US-DISC-002·Q.8/A.8, bullet 1AI-verified
Disclose material study design/methodology factors
warningneeds human judgment
US-DISC-003·Q.8/A.8, bullet 1AI-verified
Disclose material limitations of study design, methodology, and results
warningneeds human judgment
US-DISC-004·Section VI, Recommendation 3AI-verified
Firm representatives should disclose their firm affiliation in public responses
warningcheckable
US-DISC-005·Section V, Q2Disputed
Provide a copy of or mechanism to obtain current FDA-required labeling
warningcheckable
US-DISC-006·Section V, Q2Disputed
Disclose authors/contributors with firm financial relationships
warningneeds human judgment
US-DISC-007·Section V, Q2AI-verified
Describe all material aspects of study design, methodology, and results for study-focused source publications
warningneeds human judgment
US-DISC-008·Section V, Q2Disputed
Describe all material limitations of study design, methodology, and results
warningneeds human judgment
US-DISC-009·Section V, Q2Disputed
State the publication date of referenced source publications
notecheckable
US-DISC-010·Section V, Q3, item 1AI-verified
Present required disclosures clearly and prominently
warningneeds human judgment
US-DISC-011·Section V, Q3, item 1AI-verified
Match audio and text disclosures for audio-visual SIUU communications
warningcheckable
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-DISC-014·Section V, Q5AI-verified
Firm-generated presentation should identify firm-generated portions
warningcheckable
US-DISC-015·Section V, Q5Draft
Firm-generated presentation should follow safety claims with contributor disclosure
warningcheckable