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-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