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Comment & Response
November 2018

Information Transparency in the Drug Approval Process—Reply

Author Affiliations
  • 1Program on Regulation, Therapeutics and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
  • 2Davidoff Cancer Center, Rabin Medical Center, Petach Tikvah, Israel
JAMA Oncol. 2018;4(11):1622. doi:10.1001/jamaoncol.2018.4163

In Reply We read with interest the letter by Rini and colleagues in response to our Viewpoint,1 and we thank them for making us aware of the substantial information available at the US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) website.2 However, we still believe that there was excessive focus on disease-free survival (DFS) over overall survival (OS) at the committee meeting, for 2 main reasons.

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