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
4 of 251 rules
US-DISC-015·Section V, Q5Draft
Firm-generated presentation should follow safety claims with contributor disclosure
warningcheckable
US-FB-012·Section III.B.1, QuantityDraft
Risk information should increase as benefit information increases
warningneeds human judgment
US-MIS-049·Section III.C.2, Non-Print Promotion, Textual ElementsDraft
Qualifying SUPERs should appear close enough to the claim they qualify
warningneeds human judgment
US-MIS-054·Section III.C.2, Non-Print Promotion, Textual ElementsDraft
Risk-related SUPERs should not compete with unrelated SUPERs on screen
warningneeds human judgment