| Generic AI Review | OPDP Intelligence | |
|---|---|---|
| Origin | Built by engineers without regulatory enforcement background | Built on the judgment of a former FDA/OPDP Division Director with 15 years of enforcement oversight — creator of FDA's Bad Ad Program |
| Knowledge base | General internet-scale training data | Curated FDA enforcement letters, statutes, regulations, guidance, and case law |
| Output | A score or opinion, often without a clear source | Explainable, citation-backed risk assessment |
| Methodology | Ad hoc prompting, inconsistent between runs | Structured framework: Regulatory Principles, Evaluation Gateways, Evidence Weighting |
| Precedent grounding | None, or vague and unverifiable | Direct mapping to specific FDA enforcement actions |
| Auditability | Limited or no traceable reasoning | Full citation trail for every finding |
| Role in your process | Positioned as a shortcut or replacement | Decision support that feeds into your existing MLR and legal review |
| Consistency | Varies with the prompt and the reviewer using it | Applied consistently across reviewers, brands, and campaigns |
Built on the judgment of a former FDA/OPDP Division Director.
See the difference on your own materials.
Compare an explainable, citation-backed assessment against your current review process.