News and Press Releases

Natural History Studies for Rare Disease Product Development: Orphan Products Research Project Grant (R01)

Funding Opportunity Announcement (FOA) Number: RFA-FD-16-043
Open Date (Earliest Submission Date): August 15, 2016 for October 14, 2016 application due date.
Open Date (Earliest Submission Date): August 15, 2018 for October 15, 2018 application due date
Letter of Intent Due Date(s): August 31, 2016 for October 14, 2016 application due date.
Letter of Intent Due Date(s): August 31, 2018 for October 15, 2018 application due date.
Application Due Date(s): October 14, 2016 and October 15, 2018, by 11:59 PM Eastern Time
http://grants.nih.gov/grants/guide/rfa-files/RFA-FD-16-043.html

Purpose: The objective of FDA's Orphan Products Natural History Grants Program is to support studies that advance rare disease medical product development through characterization of the natural history of rare diseases/conditions, identification of genotypic and phenotypic subpopulations, and development and/or validation of clinical outcome measures, biomarkers and/or companion diagnostics. The ultimate goal of these natural history studies is to support clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for natural history studies that will either assist or substantially contribute to market approval of these products.

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