This article highlights the author’s experiences as a patient advocate serving on the Food and Drug Administration (FDA) Biological Response Modifiers Committee. It provides an overview of the National Organization for Rare Disorders and the scope of the orphan disease problem. The author explains the process of serving on an advisory committee, and highlights the important role of patient advocates in protecting the patient’s best interests.
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Presented at the DIA 35th Annual Meeting, June 27–July 1, 1999, Baltimore, Maryland.
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Meyers, A.S. The Patient Advocate Perspective on Preparing for FDA Advisory Committee Presentations. Ther Innov Regul Sci 34, 969–973 (2000) doi:10.1177/009286150003400330
- Orphan drugs
- FDA advisory committees
- National Organization for Rare Disorders