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
9 of 251 rules
US-FB-019·Section III.C.1, Font Size and StyleAI-verified
Use similar type styles for risk and benefit information
noteneeds human judgment
US-MIS-050·Section III.C.2, Non-Print Promotion, Textual ElementsAI-verified
Do not rely on a single line of text for complex qualifying information
noteneeds human judgment
US-NAME-036·Section II.D.2AI-verified
Established name should be on screen as long as the proprietary name
noteneeds human judgment
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
US-SUB-009·Section V, Recommendation 3AI-verified
Rely on published peer-reviewed or independent-source data to the greatest extent possible
noteneeds human judgment
US-SUB-010·Section V, Recommendation 3AI-verified
Use reprints only from journals with a stated conflict-of-interest disclosure policy
noteneeds human judgment
US-SUB-011·Section V, Recommendation 6Disputed
Provide a complete reference list for all information disseminated in the response
noteneeds human judgment