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    Temporary Importation of a Prescription Pharmaceutical Product

    This article offers a hypothetical scenario in which a company manufacturing a drug to treat a rare genetic disease must cease manufacturing because of a serious manufacturing problem. The authors discuss step-by-step how the company should obtain an exemption from FDA to temporarily import the same product approved for use in another country, thereby providing US patients with their drug during the interim drug shortage caused by a manufacturing issue in its US facilitie...