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 — including rules the source does not limit to any one scope
US-ADM-001·21 CFR 202.1(j)(1)(i)-(iii)AI-verified
Ads with unpublicized fatality/serious-damage information require prior FDA approval once FDA so notifies
blockerneeds human judgment
US-ADM-002·21 CFR 314.81(b)(3)(i)AI-verified
Submit Promotional Labeling Specimens at Initial Dissemination
blockercheckable
US-ADM-003·21 CFR 314.81(b)(3)(i)AI-verified
Submit Prescription Drug Ad Specimens at Initial Publication
blockercheckable
US-ADM-004·21 CFR 314.81(b)(3)(i)AI-verified
Submit Sample-Carrying Mailers Complete, Minus the Physical Sample
blockercheckable
US-ADM-005·21 CFR 314.81(b)(3)(i)AI-verified
Attach Completed Form FDA-2253 to Ad/Labeling Submissions
blockercheckable
US-ADM-006·21 CFR 314.81(b)(3)(i)AI-verified
Include Current Professional Labeling With Ad/Labeling Submissions
blockercheckable
US-ADM-007·21 CFR 314.550AI-verified
Submit promo materials for FDA review if disseminated within 120 days of approval
blockercheckable
US-ADM-008·21 CFR 314.550AI-verified
After 120 days post-approval, submit promo materials 30 days before use
blockercheckable
US-ADM-009·21 CFR 601.45AI-verified
Submit pre-approval-window promotional materials during preapproval review
blockercheckable
US-ADM-010·21 CFR 601.45AI-verified
Submit post-approval promotional materials at least 30 days before use
blockercheckable
US-ADM-011·21 CFR 601.12(f)(4)AI-verified
Submit advertisements and promotional labeling to FDA per 314.81(b)(3)(i)
blockercheckable
US-ADM-012·Q.8/A.8, concluding paragraphAI-verified
Qualified personnel should review CFL promotional communications before dissemination
notecheckable