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
13 of 251 rules — including rules the source does not limit to any one scope
US-IND-001·21 CFR 202.1(e)(3)(ii)AI-verified
Effectiveness claims in Rx drug ads must state specific approved indications
blockerneeds human judgment
US-IND-002·21 CFR 202.1(e)(4)(i)(a)AI-verified
Ads for post-1962-NDA/1969-NADA/§572-index drugs may not suggest unapproved uses
blockerneeds human judgment
US-IND-003·21 CFR 202.1(e)(6)(xi)AI-verified
Literature may not suggest unapproved conditions of use (Rx drugs)
blockerneeds human judgment
US-IND-004·21 CFR 202.1(e)(6)(xii)AI-verified
Fixed-combination Rx ads limit indication to concomitant-therapy patients
blockerneeds human judgment
US-IND-005·21 CFR 202.1(e)(6)(xix)Disputed
Dosage safe for one patient class may not be implied safe/effective for another
blockerneeds human judgment
US-IND-006·21 CFR 601.12(a)(4)AI-verified
Update promotional labeling and advertising promptly after a labeling change
blockerneeds human judgment
US-IND-007·Q.2/A.2, Factor 1 (Indication)AI-verified
Communication must not suggest an indication different from labeling
blockerneeds human judgment
US-IND-008·Q.2/A.2, Factor 1 (Patient Population)AI-verified
Communication must not suggest use outside approved patient population
blockerneeds human judgment
US-IND-009·Q.2/A.2, Factor 1 (Limitations and Directions for Handling/Use)AI-verified
Communication must not conflict with labeled use limitations or handling directions
blockerneeds human judgment
US-IND-010·Q.2/A.2, Factor 1 (Dosing or Use Regimen/Administration)AI-verified
Communication must not conflict with labeled dosing, regimen, route, or strength
blockerneeds human judgment
US-IND-011·Q.2/A.2, Factor 2AI-verified
Communication is not consistent with labeling if it increases potential for harm relative to labeling
blockerneeds human judgment
US-IND-012·Q.2/A.2, Factor 3Disputed
Communication is not consistent when labeling does not enable safe and effective use as suggested
blockerneeds human judgment
US-IND-013·Section V, Recommendation 6 (A prominent statement disclosing the indication(s) for which FDA has approved or cleared the product bullet)Disputed
Disclose the product's FDA-approved indication(s) prominently in the response
warningneeds human judgment