Hi Carrie, The contact we have at the FDA is Richard A. Forshee, who is the
Associate Director for Research at the Office of Biostatistics &
Epidemiology, in the Center for Biologics Evaluation and Research. He
arranged for the FDA to do this evaluation of CEM. They then evaluated the
software, quizzed us about various features and processes, and they made
their decision.
Best of luck with your research,
Gary
--
*Gary King* - Albert J. Weatherhead III University Professor - Director,
IQSS <http://iq.harvard.edu/> - Harvard University
GaryKing.org - King(a)Harvard.edu - @KingGary <https://twitter.com/kinggary> -
617-500-7570 - Assistant <king-assist(a)iq.harvard.edu>: 617-495-9271
On Mon, Aug 28, 2017 at 1:18 PM, Carrie Bennette <cb11(a)uw.edu> wrote:
> 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*
>
>
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*
