Grant: The Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD) is pleased to announce availability of funds for fiscal years (FY) 2021 – FY 2022 to support innovative and efficient clinical trials 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.
Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (RO1):
Receipt Dates: October 6, 2020, October 5, 2021
Other important info:
Plazo de Presentación: October 6, 2020, October 5, 2021
Entidad Financiadora: Food and Drug Administration’s (FDA) Office of Orphan Products Development (OOPD)
Plazo de Presentación: 06/10/2021