AI-powered analysis of pharmaceutical promotional video content against FDA enforcement patterns, delivering explainable compliance alerts.
Promotional video content from Veeva PromoMats is automatically indexed by cQuenced for multimodal analysis.
Our algorithm matches 14 FDA enforcement patterns extracted from 34 OPDP letters against your content.
Explainable alerts identify exactly what was detected, which FDA letters cite the pattern, and what CFR section applies.
Measures attention-grabbing visual elements during major statement (risk information) that may interfere with comprehension
Measures whether visual and audio claims align with approved labeling and clinical trial results
Measures the equality of prominence between benefit and risk presentations
Measures accessibility of full prescribing information
Measures content freshness, rights status, and claims validity
Calibrated against FDA OPDP enforcement decisions across 34 letters and 30 analyzed brands
The monitoring algorithm is built on 34 verified FDA OPDP untitled letters issued between September 2025 and February 2026. Each letter is analyzed to extract specific violation patterns — 14 unique pattern categories covering visual elements, claims, and presentation issues that FDA cited as violations.
When new FDA enforcement letters are published, the algorithm is updated to incorporate new patterns. Each update increases the detection coverage and refines pattern matching accuracy.
Content analysis is powered by cQuenced's multimodal video intelligence platform, which analyzes visual scenes, transcript timing, on-screen text, and motion patterns. Results are matched against the FDA enforcement pattern catalog using deterministic scoring rules tied to specific Code of Federal Regulations citations.
Every alert includes full explainability: which pattern was detected, which FDA letters previously cited the same pattern, the relevant CFR section, and timestamped video evidence.