FDA new grant funding opportunity: Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (RO1)

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

• FOA Number: RFA-FD-21-001

Other important info:

• Purpose: To fund well-controlled studies in support of a new indication or change in labeling of products to address unmet needs in rare diseases or conditions.
• Focus: Efficiency, innovation, impact, and added focus on leveraging patient input, infrastructure and financial resources
• Innovation: Inclusion of a new optional innovative demonstration project
• Contact: Katherine Needleman, Director, Orphan Products Grants Program
  E-mail: [email protected]

Plazo de Presentación: October 6, 2020, October 5, 2021

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