Posted by Michael Wonder on 01 Dec 2017
FDA aims to expand early approval program for promising drugs
30 November 2017 - Scott Gottlieb speaks before House subcommittee on health.
The FDA wants to help patients get faster access to promising cancer treatments.
The agency is preparing proposals that would expand an accelerated-approval program for lifesaving medications, FDA Commissioner Scott Gottlieb told House law makers on Thursday.
Drug makers can seek rapid conditional approval for treatments for cancer or other serious diseases based on evidence that a drug is likely to extend patient survival. Later trials once such a drug is on the market are necessary to prove the survival benefit.
