NASH Drug Development: Experts Argue The Case For Noninvasive Tests As Surrogate Endpoints For Approval

 
• By Sue Sutter

However, FDA officials appear skeptical that imaging-based and circulating biomarkers are ready for prime time when it comes to supporting accelerated approval of drugs for noncirrhotic nonalcoholic steatohepatitis.

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An FDA official cautioned against trying to build a surrogate on a surrogate. • Source: Shutterstock

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