• Federal register · Jun 2013

    Orphan drug regulations. Final rule.

    • Food and Drug Administration, HHS.
    • Fed Regist. 2013 Jun 12; 78 (113): 35117-35.

    AbstractThe Food and Drug Administration (FDA) is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.

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