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.
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