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
6 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-006·Section V, Q2Disputed
Disclose authors/contributors with firm financial relationships
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-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