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
36 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-009·Section V, Q2Disputed
State the publication date of referenced source publications
notecheckable
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-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-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
US-IND-014·Section V, Q2Disputed
Disclose the FDA-approved use(s) and labeling limitations
warningcheckable
US-MIS-002·21 CFR 202.1(e)(3)(i)Disputed
Misleading omissions in prescription drug ads require added qualification within that part/theme
blockerneeds human judgment
US-MIS-013·21 CFR 202.1(e)(6)(xiv)Disputed
No misleading pooled statistics in prescription drug advertising
blockerneeds human judgment
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-008·21 CFR 202.1(b)(1)Disputed
Established name must appear with proprietary name in running text
blockerneeds human judgment
US-NAME-011·21 CFR 202.1(b)(2)Disputed
Established-name lettering ≥ half size of featured proprietary name in Rx drug ads
blockerneeds human judgment
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-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-038·Section II.D.2Disputed
Audio portion of audiovisual/broadcast material need not include established name
notecheckable
US-NAME-047·Section IIIDisputed
Combination products: active ingredients should be placed directly right of or below proprietary name
warningneeds human judgment
US-RISK-001·21 CFR 202.1(e)(1)-(3)Disputed
Prescription drug ads need true brief summary, with broadcast alternative
blockerneeds human judgment
US-RISK-020·Section V, Recommendation 6 (A copy of the FDA-required labeling bullet)Disputed
Accompany unsolicited-request response with FDA-required labeling, if any
warningcheckable
US-RISK-021·Section V, Recommendation 6 (A prominent statement notifying … bullet)Disputed
State prominently that FDA has not approved or cleared the discussed use
warningneeds human judgment
US-RISK-022·Section V, Recommendation 6 (A prominent statement providing … bullet)Disputed
Include prominent statement of all important safety information, including any boxed warning
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-001·21 CFR 312.7(a)Disputed
Full Scientific Exchange About an Investigational Drug Is Not Restricted
noteneeds human judgment
US-SCI-003·Section V, Recommendation 2Disputed
Response to an unsolicited request should be tailored to the specific question asked
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-011·Section V, Recommendation 6Disputed
Provide a complete reference list for all information disseminated in the response
noteneeds human judgment
US-SUB-016·Section V, Q2Disputed
Disclose conflicting conclusions from other scientifically sound studies, with citations
warningneeds human judgment