Hello,
I'm very interested in using CEM for some projects evaluating oncology
therapies, some of which may be submitted to the FDA. Could someone provide
more context regarding the note on the CEM website that CEM has officially
been "Qualified for Scientific Use" by the U.S. Food and Drug
Administration as I've not seen this designation used before? I'm
particularly interested in understanding what criteria the FDA used in
granting this designation and, if applicable, which group within the FDA
(e.g. CDER, CBER, CDRH) granted it.
Thanks!
Carrie
--
*Carrie Bennette, PhD, MPH*
*Senior Methodologist, Quantitative Sciences, Flatiron Health*
*Affiliate Assistant Professor, Department of Pharmacy, University of
Washington*
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