Rules

Aboutfair balance risk disclosure indication on label substantiation comparative misleading presentation name ingredient submission pre approval scientific exchange disclosure

TrustAI-verified Disputed Draft

Severityblocker warning note

Decided bya check human judgment

Naturepromotional

Basisconsistent-with-labeling unsolicited-request unapproved-use-scientific

Audiencehcp consumer

Document typeadvertisement

Risk info placementdistinct-part

Communication typeadvertisement

Mediumprint broadcast digital social in-person

Regulatory classprescription-drug

Material typeprescription-drug-advertisement advertisement

Launch stagepost-approval pre-approval

Productdrug biologic prescription-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 exemptionexcludes-reminder-ads excludes-bulk-sale-drug-ads excludes-prescription-compounding-drug-ads

Ad formattelevision

Intended specieshuman

Exemption statusnon-exempt

Approval pathwayaccelerated

3 of 251 rules

US-DISC-004·Section VI, Recommendation 3AI-verified

Firm representatives should disclose their firm affiliation in public responses

warningcheckable

US-DISC-011·Section V, Q3, item 1AI-verified

Match audio and text disclosures for audio-visual SIUU communications

warningcheckable

US-DISC-014·Section V, Q5AI-verified

Firm-generated presentation should identify firm-generated portions

warningcheckable