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September 06, 2006

Taking it personal(ized)

by Peter Pitts

What’s the trade-off between quality and speed? Can’t we have both? While this is a regular debate in the world of pharmaceutical development — it’s not so familiar in the realm of diagnostics. Until now — and it’s about time.

The issue at hand is FDA’s new draft guidance on a new category of complex diagnostic tests that are expected to play a growing role in tailoring medical treatments to specific patients.

Here’s a link to the FDA announcement:

http://www.fda.gov

I also suggest, as recommended reading, an article in today’s edition of the New York Times by the always thoughtful Andrew Pollack. (Sorry — I am not able to provide a hot link, but the title is “F.D.A. Seeks to Regulate New Types of Diagnostic Tests.”)

Please note that this is a draft guidance — the agency is accepting comments. Now is the time to help the FDA design a final guidance that will allow for both speedier approval and higher quality.

It can be done. It must be done.

Posted by Peter Pitts at September 6, 2006 07:44 AM

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