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        Medical products for rare diseases and conditions

Orphan Products Grants Program Home
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          Medical products for rare diseases and conditions
          Orphan Products Grants ProgramMedical products for rare diseases and conditions Orphan Products Grants Program
  	
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    PrintThe 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.

Contact

Program Questions: Mary Limon
	Scientific/Research Questions: Katherine Needleman
	Budget Questions: Kimberly Pendleton
	Technical application submission questions: eRA Service Desk
	FDA’s Office of Orphan Products Development main number: 301-796-8660

Additional resources

Clinical Trials and Natural History Studies Grants Program
	Rare Neurodegenerative Disease Grant Program
	Funding Opportunities for rare disease research
	Frequently Asked Questions
	Resources for Applicants and Grantees
	Orphan Grants Spotlight
	Office of Orphan Products Development

                                                                                  Content current as of:
      12/13/2023Orphan Products Grants Program
 
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