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NASH Drug Development Questions? US FDA Has Many Of The Answers

 
• By Brenda Sandburg

From biomarkers to treatment effect size, agency officials respond to some of more than a hundred questions that poured in during a webinar on development of drugs to treat the liver disease.

Liver
FDA officials address questions about development of drugs for NASH liver disease • Source: Shutterstock

The US Food and Drug Administration was deluged with questions during a webinar on the development of new drugs to treat non-alcoholic steatohepatitis (NASH), showing how hot the area is in pharma R&D and the issues of concern to sponsors, from the use of biomarkers to the length of trials.

In opening the 29 January webinar, Toru Matsubayashi, a medical reviewer in the Division of Hepatology and Nutrition, noted some unique challenges inherent in drug development for NASH

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