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
12 of 251 rules
US-SCI-009·Section VI, Recommendation 2AI-verified
Public response should include specific medical/scientific contact information
warningcheckable
US-SCI-010·Section VI, Recommendation 2AI-verified
Detailed off-label response should not be posted publicly in the same forum
warningcheckable
US-SCI-013·Section V, Q3, item 2, Example 2AI-verified
Host SIUU communications on a separate web page from approved-use promotion
warningcheckable
US-SCI-014·Section V, Q3, item 2, Example 2AI-verified
Do not link directly from approved-use promotional pages to SIUU pages
warningcheckable
US-SCI-015·Section V, Q3, item 2, Example 3AI-verified
Keep SIUU email messages separate from approved-use promotional emails
warningcheckable
US-SCI-018·Section V, Q4, item 1 (Reprints)AI-verified
Share reprints unaltered and unabridged
warningcheckable
US-SCI-021·Section V, Q4, item 1 (Reprints)AI-verified
Reprinted article or its journal must be generally available through independent channels
warningcheckable
US-SCI-023·Section V, Q4, item 2 (Clinical Reference Resources)AI-verified
Excerpted clinical reference resource sections must be unaltered and extracted directly
warningcheckable
US-SCI-025·Section V, Q4, item 2.a (CPGs)AI-verified
Shared CPG must rate the strength/quality of evidence for its recommendations
warningcheckable
US-SCI-027·Section V, Q4, item 2.a (CPGs)AI-verified
Shared CPG must be generally available through independent distribution channels
warningcheckable
US-SCI-031·Section V, Q4, item 2.b (Reference Texts / Digital Clinical Practice Resources)AI-verified
Shared reference text/digital resource must be generally available through independent channels
warningcheckable
US-SCI-033·Section V, Q5AI-verified
Firm-generated presentation must be provided together with the source publication
warningcheckable