Nonalcoholic Steatohepatitis: Current Thinking From the Division of Hepatology and Nutrition at the Food and Drug Administration.

HEPATOLOGY(2021)

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摘要
As part of a larger reorganization of the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) Office of New Drugs, the former Division of Gastroenterology and Inborn Errors Products (DGIEP) has been divided into three review divisions with more focused disease areas, including the new Division of Hepatology and Nutrition (DHN). DHN's review activities are focused on three general areas: (1) drug development and review of early and late phase clinical trials of drugs for treatment of specific diseases of the liver, (2) consultations from any FDA review division on drug-induced liver injury (DILI), and (3) development and review of early and late phase clinical trials for nutrition products.
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