The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce availability of funds for to support natural history studies for rare diseases and conditions. These studies are intended to provide acceptable data to the FDA that will substantially contribute to the approval of new products, or new indications for already marketed products. In the FDA OOPD Orphan Products Grants Program, products for rare diseases and conditions (orphan products) are defined as drugs, biologics, medical devices, and medical foods indicated to treat or diagnose a rare disease or condition with a prevalence of fewer than 200,000 people in the United States.
Apply here: Efficient and Innovative Natural History Studies Addressing Unmet Needs in Rare Diseases (R01)
- Receipt Date: February 15, 2022 and February 13, 2024
- FOA Number: RFA-FD-22-001
Purpose: To support efficient and innovative natural history studies that advance medical product development in rare diseases/conditions with unmet needs.
Focus: Natural history studies with high quality and interpretable data elements
Contact: Katherine Needleman, Director, Orphan Products Grants Program
