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
8 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