Vanda Demands FDA Revise NAM Guidance Missing Validated Assays, Approval Pathways
Vanda Pharmaceuticals criticized the FDA's March 18 draft guidance on New Approach Methodologies for drug development, highlighting absence of any concrete NAM examples, validation benchmarks, or clear approval pathways. The company urged withdrawal and revision with specific citations, expedited regulatory paths, and industry collaboration to accelerate human-relevant testing and ethical drug safety.
1. FDA’s New Approach Methodologies Draft Guidance
The FDA released draft guidance on March 18 to modernize nonclinical testing by promoting New Approach Methodologies—such as in vitro assays, organ-on-chip systems, computational models, and human cell-based platforms—to reduce reliance on traditional animal studies.
2. Vanda’s Critique and Recommended Revisions
Vanda Pharmaceuticals applauds the shift toward human-relevant science but argues the draft offers no named assays, case studies, performance data or streamlined approval pathways. The company called for withdrawal and substantial revision with robust citations, concrete examples of accepted NAMs and clear regulatory criteria.
3. Potential Impact on Drug Development
Without specific benchmarks or expedited pathways, developers face uncertainty that could delay adoption of more predictive testing tools. Vanda warns that stronger guidance and industry-agency collaboration are essential to accelerate safer, faster drug development and improve patient access.