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
6 of 251 rules
US-DISC-009·Section V, Q2Disputed
State the publication date of referenced source publications
notecheckable
US-NAME-020·Section II.ADisputed
Trademark and controlled-substance symbols do not count as intervening matter
notecheckable
US-NAME-026·Section II.BDisputed
Type size is measured by actual letter height, not point size
notecheckable
US-NAME-037·Section II.D.2AI-verified
Bottom-of-screen supers do not require the established name
notecheckable
US-NAME-038·Section II.D.2Disputed
Audio portion of audiovisual/broadcast material need not include established name
notecheckable
US-ADM-012·Q.8/A.8, concluding paragraphAI-verified
Qualified personnel should review CFL promotional communications before dissemination
notecheckable