New Request for Information (RFI) Released by the Advanced Research Projects Agency for Health (ARPA-H) Solicits Ideas for Engaging with the FDA on Regulatory Strategies for Health Innovations
ARPA-H, or the Advanced Research Projects Agency for Health, is a new agency within the National Institutes of Health (NIH) that aims to accelerate the development of breakthrough technologies and treatments for major diseases. ARPA-H first released a Broad Agency Announcement (BAA) on March 15th to solicit input from the scientific community on potential research areas and approaches (see https://everglade.com/funding-opportunities-arpa-h/).
As a part of its efforts to facilitate the successful development and transition of health innovations into safe and effective solutions, ARPA-H is partnering with the FDA to address pre-competitive challenges that might help an emerging area and to develop pathways and services for performers to accelerate the impact of their solutions. ARPA-H can create new incentives for performers to participate in public-private partnerships and can financially reimburse the FDA for activities that support ARPA-H priorities.
The recently released Request for Information (RFI) seeks novel insights, ideas, incentives, approaches, and models to accelerate innovation while prioritizing patient safety. The purpose of the RFI is to understand the possibilities under the current regulatory and statutory paradigm, and not to propose changes to FDA regulatory authority or statutes. The US Government is looking for specific practices to speed up approvals and support emerging health innovations.
Specifically, the RFI is looking for the following:
- Proposals on new and innovative models to accelerate the pre-competitive development of platform technologies
- Proposed applications of ARPA-H’s authority to reimburse FDA activities to support emerging areas or pathbreaking innovations
- Strategies to accelerate alternatives to traditional human or animal research for medical product development.
- Strategies for using real-world evidence and other post-market surveillance methodologies to understand gaps in care and how to scale novel therapies to all populations.
- Case studies that highlight best practices for using existing FDA regulatory pathways and specific opportunities for R&D innovation supported by ARPA-H to enhance or accelerate the use of existing FDA regulatory pathways for novel or transformative medical products.
- Proposed models for how ARPA-H could best support its performers on regulatory topics
The complete RFI can be found at https://arpa-h.gov/assets/files/RFI_ARPA-H_FDA.pdf. Responses (5-page limit) are due by May 30, 2023. If you are interested in exploring ARPA-H opportunities, EverGlade can help.