Regulatory Open Forum

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  • 1.  Orphan Drug Final Rule

    Posted 15-Nov-2013 01:06
    Hi All,

    This is regard to the orphan drug act prior to the final rule. Is it possible to have a subset of a rare disease? If yes, does it fall into the medically plausible subset or just the rare disease?

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