In recent study published in the journal Clinical Gastroenterology and Hepatology, researchers outline the elements of an investigational new drug application for FMT.
• Product name/chemical structure
• Proposed indications
• Dosage and route of administration
• Background
• Chemistry, manufacturing and controls information
• Clinical data summary
• FMT treatment protocol
• Adverse event report
• Risks associated with FMT
• Safety monitoring protocol
Submission of a new drug application for FMT would also require additional forms, local institutional review board approval and case report forms.
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