Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01)

The purpose of this funding opportunity announcement (FOA) is to support clinical studies of products that address unmet needs in rare diseases or conditions or provide highly significant improvements in treatment or diagnosis.

Through the support of efficient and innovative clinical studies

evaluating safety and/or effectiveness, FDA expects to increase the number of treatments for rare diseases with an unmet medical need and support studies that will either result in market approval of these products or substantially contribute to the essential data needed for medical product development that will ultimately meet the needs of rare disease patients.

Related Programs

Food and Drug Administration Research

Department of Health and Human Services


Agency: Department of Health and Human Services

Office: Food and Drug Administration

Estimated Funding: $6,000,000


Who's Eligible


Relevant Nonprofit Program Categories



Obtain Full Opportunity Text:
Full application announcement

Additional Information of Eligibility:
Other Eligible Applicants include the following: Eligible Agencies of the Federal Government; Regional Organizations; U. S. Territory or Possession.

Full Opportunity Web Address:
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-20-001.html

Contact:


Agency Email Description:
daniel.lukash@fda.hhs.gov

Agency Email:


Date Posted:
2018-10-23

Application Due Date:


Archive Date:
2019-07-25



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