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
3 of 251 rules
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