Summary
The FDA is soliciting research applications for efficient and innovative natural history studies that address unmet needs in rare diseases. This is a reissue of the prior funding opportunity RFA-FD-22-001, now designated RFA-FD-25-017. The mechanism is an R01 grant, with clinical trials listed as optional. The opportunity is open for an extended multi-year window, running from July 2025 through February 2028, indicating a rolling or multi-cycle submission structure. The goal is to advance understanding of rare disease progression and inform future regulatory and therapeutic development efforts.
