FDA Aims to Expand Early-Approval Program for Promising Drugs

Source: Bloomberg

Friday, December 01, 2017 | FDA Approval/Clearance , Health Care


The Food and Drug Administration 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 lawmakers on Thursday, as reported in Bloomberg.

Drugmakers 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.
 


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