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U.S. Department of Health and Human Services

For Industry

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FDA Rare Disease Patient Advocacy Day

On March 1, 2012, the Food and Drug Administration (FDA) celebrated the fifth annual Rare Disease Day by hosting a "FDA Rare Disease Patient Advocacy Day" to engage and educate the rare disease community on regulatory processes related to rare diseases.

This meeting was held to enhance the awareness of the rare disease community as to FDA’s roles and responsibilities in the development of products (drugs, biological products and devices) for the diagnosis, prevention, and/or treatment of rare diseases or conditions. 


FDA Rare Disease Patient Advocacy Day logo

Meeting Evaluation: The FDA values your review of this event. We encourage participants to contact us with your comments at: orphan@fda.hhs.gov


Video Recording of March 01, 2012 event:


Recap of the Patient Advocacy Day Meeting:







The FDA Rare Disease Patient Advocacy Day is supported by the Food and Drug Administration (FDA), the National Institutes of Health (NIH), the National Organization for Rare Disorders (NORD), and the Genetic Alliance.

NIH 2012  Rare Disease Day logo