Gottlieb Outlines Steps For Streamlining Cancer Drug Approvals

November 30, 2017 at 6:32 PM
FDA is developing a policy by which the agency can approve subsequent indications of cancer drugs with less rigorous follow-up trials, FDA Commissioner Scott Gottlieb announced Thursday (Nov. 30). The agency will also provide more guidance on how FDA believes it can approve treatments based on intermediate clinical endpoints, which one expert explained may be significant when exploratory or so-called go-no-go trials show a significant improvement and time is of the essence to get the drugs approved. Both moves by...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.