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Process to Provide Tecovirimat (EPOXY) for Treatment of Monkey pox (Updated as of 9/7/2022) Tecovirimat (EPOXY) is an antiviral medication that is approved by the United States Food and Drug Administration
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A US clinical trial evaluates the safety and effectiveness of a medical treatment or device.
The sponsor or principal investigator of the clinical trial is required to file.
The trial must be conducted according to the protocol, and all data must be accurately recorded and reported.
The purpose is to gather data to determine if the treatment or device is safe and effective for use in humans.
Information such as the study protocol, informed consent forms, adverse event reports, and study results must be reported.
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