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NASH Accelerated Approval: US FDA Remains Confident In Pathway For Liver Disease

 
• By Michael McCaughan

A two-day workshop on potential biomarkers in NASH provided a forum for US FDA officials to offer implicit reassurance to drug developers: the agency stands behind its guidance on Accelerated Approval for the liver disease, despite the rejection of the first application seeking to use that approach.

MASH-NASH
NASH (non-alcoholic steatohepatitis) is now also known as MASH (metabolic dysfunction associated steatohepatitis). • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock images

US FDA review officials believe the experience with post-marketing cardiovascular outcomes trials in diabetes is a strong indication that it will be possible to complete rigorous, long-term confirmatory studies for drugs that receive Accelerated Approval to treat NASH.

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US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
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US FDA Allows Telework For Reviewers As Companies Detail Layoff-Related Problems

 
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