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
18 of 251 rules — including rules the source does not limit to any one scope
US-SCI-001·21 CFR 312.7(a)Disputed
Full Scientific Exchange About an Investigational Drug Is Not Restricted
noteneeds human judgment
US-SCI-011·Section V, Q3, item 2AI-verified
Keep SIUU communications separate from promotional communications about approved uses
warningneeds 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-017·Section V, Q3, item 3AI-verified
Do not host SIUU communications on platforms too limited to carry the required disclosures
warningneeds human judgment
US-SCI-019·Section V, Q4, item 1 (Reprints)AI-verified
Reprint's journal should be managed by an independent organization
warningneeds human judgment
US-SCI-020·Section V, Q4, item 1 (Reprints)AI-verified
Reprinted article should be peer-reviewed by subject-matter experts
warningneeds human judgment
US-SCI-022·Section V, Q4, item 2 (Clinical Reference Resources)AI-verified
Excerpted clinical reference resource sections must include all information needed to interpret them
warningneeds human judgment
US-SCI-024·Section V, Q4, item 2.a (CPGs)AI-verified
Shared CPG must be based on a rigorous, transparent evidence review
warningneeds 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-SCI-028·Section V, Q4, item 2.b (Reference Texts / Digital Clinical Practice Resources)AI-verified
Shared reference text/digital resource should come from an independent scientific/medical publisher
warningneeds human judgment
US-SCI-029·Section V, Q4, item 2.b (Reference Texts / Digital Clinical Practice Resources)AI-verified
Shared reference text/digital resource must follow accepted content-creation and peer-review standards
warningneeds human judgment
US-SCI-030·Section V, Q4, item 2.b (Reference Texts / Digital Clinical Practice Resources)AI-verified
Shared reference text/digital resource should be authored by demonstrated subject-matter experts
warningneeds human judgment
US-SCI-032·Section V, Q5AI-verified
Firm-generated presentation should be limited to scientific information from its source publication(s)
warningneeds human judgment
US-SCI-034·Section V, Q5AI-verified
Do not use calls to value that pre-judge patient benefit
warningneeds human judgment
US-SCI-035·Section V, Q5AI-verified
Do not use persuasive marketing techniques unrelated to scientific content
warningneeds human judgment
US-SCI-036·Section V, Q4, item 1 (Reprints)AI-verified
Reprint's journal editorial board should have demonstrated expertise
warningneeds human judgment
US-SCI-037·Section V, Q4, item 1 (Reprints)AI-verified
Reprint's journal should have a public conflict-of-interest disclosure policy
warningneeds human judgment
US-SCI-038·Section V, Q5Disputed
Source publication(s) for a firm-generated presentation must meet Q1 and Q4 recommendations
warningneeds human judgment