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
18 of 251 rules — including rules the source does not limit to any one scope
US-DISC-005·Section V, Q2Disputed
Provide a copy of or mechanism to obtain current FDA-required labeling
warningcheckable
US-DISC-006·Section V, Q2Disputed
Disclose authors/contributors with firm financial relationships
warningneeds human judgment
US-DISC-008·Section V, Q2Disputed
Describe all material limitations of study design, methodology, and results
warningneeds human judgment
US-DISC-012·Section V, Q5Disputed
Firm-generated presentation itself should include Q2 disclosures
warningcheckable
US-DISC-013·Section V, Q5Disputed
Attribute safety/effectiveness conclusions to the source publication
warningcheckable
US-FB-003·21 CFR 202.1(e)(7)(viii)Disputed
Prescription-drug ad may lack fair balance if side-effect prominence trails efficacy
warningneeds human judgment
US-FB-006·21 CFR 202.1(e)(7)(xi)Disputed
Multi-page Rx ads may lack fair balance if risk info isn't facing/full page
warningcheckable
US-FB-014·Section III.C.1, Overall Location of Risk InformationDisputed
Include risk information in the main part of the piece
warningneeds human judgment
US-FB-016·Section III.C.1, Overall Location of Risk InformationDisputed
Complete separation of benefit and risk information lacks appropriate prominence
warningneeds human judgment
US-IND-014·Section V, Q2Disputed
Disclose the FDA-approved use(s) and labeling limitations
warningcheckable
US-MIS-044·Section III.A.2, Use of SignalsDisputed
Risk information should be preceded by a signal indicating risk information follows
warningneeds human judgment
US-NAME-031·Section II.D.1Disputed
Print: established name once per page or spread suffices for featured proprietary name
warningneeds human judgment
US-NAME-035·Section II.D.2Disputed
Audiovisual/broadcast headline: place established name in conjunction with proprietary name's most prominent display
warningneeds human judgment
US-NAME-047·Section IIIDisputed
Combination products: active ingredients should be placed directly right of or below proprietary name
warningneeds human judgment
US-RISK-029·Section III.A.4, Hierarchy of Risk InformationDisputed
FDA recommends stating the most important risk information first, especially in print
warningneeds human judgment
US-RISK-034·Section III.C.1, Location of Risk Information within a Part of the Promotional PieceDisputed
Risk information should not appear only on a brief summary page
warningneeds human judgment
US-SCI-038·Section V, Q5Disputed
Source publication(s) for a firm-generated presentation must meet Q1 and Q4 recommendations
warningneeds human judgment
US-SUB-016·Section V, Q2Disputed
Disclose conflicting conclusions from other scientifically sound studies, with citations
warningneeds human judgment