Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases
Funds natural-history studies that improve preparedness for rare disease trial pathways.
The FDA OOPD Natural History Studies Grants Program, active since 2016, funds well-designed, protocol-driven natural history studies that address critical knowledge gaps in rare disease medical product development. The program operates under the R01 mechanism through NOFO RFA-FD-25-017. Studies must generate high-quality, interpretable data elements that remove major barriers to clinical trial rea…
Protocol-driven natural history studies that generate high-quality data to close knowledge gaps, enable clinical trial readiness, and advance medical product development for rare diseases and conditions.
Sign up free to see the funding breakdown
Sign up free to see the industries in scope
Sign up free to see the full eligibility
Sign up free to see how to apply
Sign up free to see the timeline
Sign up free to see where teams trip up