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MLR Compliance
FDA 21 CFR § 202.1 Compliant
Automated FDA Compliance Review for Life Sciences
Deconstruct promotional assets, verify advertising copy, and match claims against approved FDA labeling and historical precedents in real-time.
Rinvoq (Upadacitinib) print-ad
78% Compliance Score
VIOLATIONS IDENTIFIED
3 Critical / 2 Medium
EVALUATED RULES
18 Standard Rules
CRITICAL VIOLATION
SAFE-001: Boxed Warning Disclosure
The promotional print asset fails to prominently display the mandatory Boxed Warning regarding serious infections and malignancy risk in a size and prominence comparable to the main efficacy claims.
Promotional Copy
"Rinvoq helps you achieve clear skin fast."
FDA Approved Labeling
"WARNING: SERIOUS INFECTIONS, MALIGNANCY..."
WARNING VIOLATION
EFF-001: Unqualified Efficacy Claims
The print ad makes absolute claims regarding the speed of response without qualifying the statistical clinical trial duration endpoints.
⚡ Execution Logs
[10:04:12] Initializing OCR text extraction...
[10:04:14] Extracted 4,821 characters from PDF document.
[10:04:15] Matching product name: "Rinvoq".
[10:04:16] Fetching approved FDA labeling SetID: 15da6b42-d...
[10:04:18] FDA Label details resolved successfully.
[10:04:19] Launching Rule Checks Engine (21 CFR § 202.1)...
[10:04:22] Rule [SAFE-001] FAILED: Boxed Warning missing from layout.
[10:04:24] Rule [EFF-001] FAILED: Unqualified efficacy claim detected.
[10:04:25] Comparing against historical warning letters...
[10:04:27] Analysis complete. Score: 78%.
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Multimodal Asset Parsing
Support for PDFs, High-Res Print Images, Audio, and Video files. Built-in OCR and transcription extract advertising copy and visuals instantly.
CFR Part 202 Validation
Automated verification against FDA rules (21 CFR Part 202) for Fair Balance, Truthful Claims, Indication ranges, and prominent Boxed Warning placements.
Label Reference Mapping
Retrieves the latest FDA-approved prescribing labels automatically to cross-verify indication statements, contraindications, and dosage guidelines.
Warning Letter Matching
Checks promotional copy against historical OPDP warning letters to find enforcement precedents and prevent compliance warning letters.
Real-Time Auditing
Continuous Compliance from Draft to Deployment
Review copy variations, verify translations, and check layouts side-by-side with clinical evidence. Speed up the compliance lifecycle by flagging warning signals before formal review boards meet.
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