Regulatory Open Forum

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  • 1.  Orphan Drug Final Rule

    Posted 15-Nov-2013 02:23
    Hi,

    So if you consider a particular rare disease, the rare disease has many medical conditions within it. Someone develops a drug, but it treats only one of the "conditions" of the rare disease but NOT the whole disease. Is it a medically plausible subset?

    Thanks,
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    Kedar Pai
    University of Southern California
    Los Angeles CA
    United States
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