FDA’s Office of Orphan Product Development (OOPD) has opened grant opportunity to support efficient and innovative natural history studies that advance medical product development in rare diseases with unmet needs. Through the support of natural history studies with high quality and interpretable data elements, FDA expects to address critical knowledge gaps, remove major barriers to progress in the field, exert a significant and broad impact on a specific rare disease or multiple rare diseases with similar pathophysiology, and facilitate rare disease product development.
The application deadline is February 15, 2022.
|Posted Date||February 17, 2021|
|Open Date (Earliest Submission Date)||December 17, 2021; December 15, 2023|
|Letter of Intent Due Date(s)||January 14, 2022; January 12, 2024|
|Application Due Date(s)||February 15, 2022|