Schaeffer experts submitted comments to the Food and Drug Administration (FDA) in response to the agency’s proposed Expedited Investigational New Drug (IND) Pilot Program. The comments noted value in FDA’s efforts to accelerate early-stage clinical development while maintaining rigorous standards for safety and scientific integrity. However, they argue that the pilot program will have the greatest impact if it is accompanied by broader modernization of the FDA’s early clinical development framework.
The comment letter emphasizes that maintaining U.S. leadership in biomedical innovation is essential for accelerating patient access to new therapies, attracting scientific investment, and sustaining economic growth. As global competition for clinical research intensifies, it’s recommended that the FDA pair the Expedited IND pilot with complementary regulatory reforms that improve efficiency across the entire development process, including late-stage development.
Specifically, Schaeffer experts recommend that the FDA:
- Update outdated guidance documents governing Phase 1 INDs and clinical review processes to better reflect current scientific and regulatory practices
- Expand support for seamless clinical development programs that allow developers to transition across trial phases under a single protocol
- Continue modernizing the regulatory framework by promoting innovative trial designs, expanding opportunities for early engagement with developers, encouraging broader use of patient preference data, and updating guidance on external control arms
Read the full comments on FDA’s proposed Expedited IND Pilot Program here.
