NASH Drug Development Guidance Encourages Sponsors To Adopt Innovative Trial Designs

Although guidance appears to be free of surprises, US FDA once again made a push for sponsors to adopt seamless trial designs.

Liver

As US FDA Commissioner Scott Gottlieb has touted the use of seamless clinical trial designs, the agency appears to promote the concept in a new draft guidance on developing drugs for the treatment of noncirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

In the guidance published Dec. 3 that otherwise contains mostly expected information, the agency says that, "Sponsors could use...

More from Clinical Trials

More from R&D