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
8 of 251 rules — including rules the source does not limit to any one scope
US-SCI-001·21 CFR 312.7(a)Disputed
Full Scientific Exchange About an Investigational Drug Is Not Restricted
noteneeds human judgment
US-SCI-002·Section V, Recommendation 1AI-verified
Send non-public unsolicited-request response only to the requestor, privately
warningneeds 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-004·Section V, Recommendation 5AI-verified
Have medical/scientific personnel independent of sales and marketing generate the response
warningneeds human judgment
US-SCI-005·Section V, Recommendation 5AI-verified
Exclude sales and marketing personnel from input on off-label response content
warningneeds human judgment
US-SCI-006·Section VI, Recommendation 1AI-verified
Respond publicly to an off-label request only when it names the firm's own product
warningneeds human judgment
US-SCI-008·Section VI, Recommendation 2AI-verified
Public response should convey the question involves an unapproved/uncleared use
warningneeds human judgment
US-SCI-039·Section VI, Recommendation 2AI-verified
Public response should direct individuals to contact medical affairs for more information
warningneeds human judgment