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Comment & Response
August 2017

Setting the Record Straight on FDA Approvals in Oncology—Reply

Author Affiliations
  • 1National Center for Health Research, Washington, DC
JAMA Intern Med. 2017;177(8):1222-1223. doi:10.1001/jamainternmed.2017.2251

In Reply The Letter to the Editor by Blumenthal and colleagues adds useful information regarding the perspective of the US Food and Drug Administration (FDA) on the approval of oncology drugs that are not proven to benefit the lives of patients. However, that information is not reassuring to physicians or patients.

The FDA refers to “four FDA programs [that] are intended to facilitate and expedite development and review of new drugs to address unmet medical need in the treatment of a serious or life-threatening condition: fast track designation, breakthrough therapy designation, accelerated approval, and priority review designation.”1

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