For Industry

FDA Recognizes Rare Disease Day 2016

Nearly 7,000 rare diseases are known to affect roughly 30 million Americans. It is estimated that about 80 percent of rare diseases are genetic and about half of all rare diseases affect children.

Rare Disease Day 2016

Rare Disease Day, which is being commemorated internationally on the rarest day of the year... February 29, was established to raise awareness about rare diseases, the challenges encountered by those affected, the importance of research to develop diagnostics and treatments, and the impact of these diseases on patients' lives.

The focus of the February 29, 2016 Rare Disease Day is the Patient Voice which pays tribute to the role that patients play in voicing their needs and in bringing about change that improves their lives and the lives of their families and caregivers.

NEW!  On Rare Disease Day 2016 the FDA announces the launch of the Orphan Products Natural History Study Grant program funding much needed natural history studies to facilitate product development for rare diseases.

Rare Disease Day Press Release

FDA Voice Blog: Launching a New Natural History Grant Program: Building a Solid Foundation for Rare Disease Treatments

Orphan Products Natural History Grant Information

Natural History Video Discussion disclaimer icon- A video discussion bringing together patients and FDA perspectives on the importance of natural history studies in the development of products for rare diseases.

A few additional highlights of FDA's recognition of Rare Disease Day 2016 activities include:

  • Partnering with NIH's Rare Disease Day conference on Monday, February 29th at NIH Masur Auditorium (Building 10), 8:30 am - 3:30 pm. For more information, Click Here
  • CDER's From Our Perspective, by Jonathan Goldsmith, M.D., Director, CDER Rare Disease Program
  • Pediatric Device Consortium Grantee meeting with stakeholders to facilitate the development of medical devices for children


The Office of Orphan Products Development (OOPD) mission is to promote the development of products for rare diseases.  For more information on OOPD programs, Click Here.

FDA's Rare Disease Council brings together cross-FDA rare disease expertise to communicate and advance the FDA's work on rare disease issues



Page Last Updated: 02/29/2016
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