FDA regulation of laboratory developed tests

[BU Pathology]

There is an interesting webinar January 8 and 9 about the potential FDA regulation of laboratory developed tests (LDT). The FDA has received complaints about lab tests that did not perform as advertised. A regulatory framework has been proposed, and the FDA is holding this 2 day meeting to solicit input. Organized pathology is making several presentations at the meeting to achieve the goal of optimal patient care.

Here is the link to the webinar.


http://videocast.nih.gov/live.asp?live=15449&bhcp=1

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