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
17 of 251 rules — including rules the source does not limit to any one scope
US-SUB-001·21 CFR 202.1(e)(6)(i)AI-verified
No unsubstantiated superiority claims (better, more effective, safer, broader use)
blockerneeds human judgment
US-SUB-002·21 CFR 202.1(e)(6)(vii)AI-verified
No implying clinical significance from nonclinical/animal/in-vitro data alone
blockerneeds human judgment
US-SUB-003·21 CFR 202.1(e)(6)(x)AI-verified
Cited literature/references must actually support the claim made
blockerneeds human judgment
US-SUB-004·21 CFR 202.1(e)(6)(xvii)AI-verified
No using data from off-label dosages to support favorable claims
blockerneeds human judgment
US-SUB-005·21 CFR 202.1(e)(7)(i)AI-verified
Favorable claims from an inadequately designed study may be misleading
warningneeds human judgment
US-SUB-006·21 CFR 202.1(e)(7)(v)AI-verified
Statistical analyses inconsistent with established statistical principles may be misleading
warningneeds human judgment
US-SUB-007·21 CFR 202.1(e)(7)(vi)AI-verified
Mechanism-of-action claims not generally established may be misleading without disclosure
warningneeds human judgment
US-SUB-008·Q.6/A.6AI-verified
Data relied on must be scientifically appropriate and statistically sound
warningneeds 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
US-SUB-012·Section V, Q1, item 1AI-verified
Source publications must describe scientifically sound studies
warningneeds human judgment
US-SUB-013·Section V, Q1, item 2AI-verified
Take existing scientific knowledge into account before and during dissemination
warningneeds human judgment
US-SUB-014·Section V, Q1, item 2AI-verified
Continuing to share a retracted source publication is inconsistent with FDA's recommendation
blockercheckable
US-SUB-015·Section V, Q1, item 3AI-verified
Conclusions in a source publication should align with the study's prespecified hypothesis or research question
warningneeds human judgment
US-SUB-016·Section V, Q2Disputed
Disclose conflicting conclusions from other scientifically sound studies, with citations
warningneeds human judgment
US-SUB-017·Section V, Q1, item 3AI-verified
Conclusions in a source publication should be supported by the study's results
warningneeds human judgment