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  1. Medical products for rare diseases and conditions

Orphan Products Grants Program

The FDA’s Orphan Products Grants Program awards grants to clinical investigators to support the development of safe and effective medical products for patients with rare diseases. The program has supported clinical research since 1983 and has funded clinical trials that have facilitated the approval of more than 80 products.

Additionally, the FDA has funded natural history studies since 2016 to help address significant unmet medical needs for patients with rare diseases. Unlike common diseases, there is little existing knowledge on the presentation, major limitations on day-to-day function, core unmet needs and course of most rare diseases which makes drug development challenging. This program funds studies that address knowledge gaps, support clinical trials and advance rare disease medical product development.


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