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  • Title: Investigational new drugs: export requirements for unapproved new drug products. Final rule.
    Author: Food and Drug Administration, HHS.
    Journal: Fed Regist; 2005 Nov 23; 70(225):70720-30. PubMed ID: 16304736.
    Abstract:
    The Food and Drug Administration (FDA) is amending its regulations on the exportation of investigational new drugs, including biological products. The final rule describes four different mechanisms for exporting an investigational new drug product. These provisions implement changes in FDA's export authority resulting from the FDA Export Reform and Enhancement Act of 1996 and also simplify the existing requirements for exports of investigational new drugs.
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