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Πέμπτη 6 Σεπτεμβρίου 2018

Information Transparency in the Drug Approval Process—Reply

In Reply We read with interest the letter by Rini and colleagues in response to our Viewpoint, 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. 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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