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FDA Tells Congress It Intends to Regulate LDTs! Web Conference to Provide Straight Talk on Essential Steps Clinical Laboratories and Pathology Groups Will Need to Take to Comply
Date:9/2/2014

AUSTIN, Texas, Sept. 2, 2014 /PRNewswire/ -- On July 31, the Food and Drug Administration sent its 60-day notice to Congress that it is moving forward to regulate laboratory-developed tests (LDTs). The clock is now ticking down the minutes until laboratories throughout the U.S. will need to comply with a host of new requirements.

Although some medical laboratories may subscribe to the strategy to simply sit back and wait for the FDA to put guidelines in place, it's widely acknowledged that failure to answer key questions now could spell disruption of a laboratory's delivery of LDT test results to clients, not to mention triggering financial chaos and possibly subjecting the lab to enforcement action by the FDA, a very powerful federal agency.

"It will benefit clinical labs and pathology groups greatly to understand what is already known about the FDA's plans—and to use that knowledge to get a head start on packaging their lab's LDTs to obtain speedy FDA clearance ahead of hundreds of other labs," said Robert L. Michel, Editor-In-Chief of The Dark Report. "To help labs at this critical moment, we are offering a timely and illuminating new webinar, hosted by a panel of consulting and legal veterans who are already up to speed with the FDA's draft guidance that it delivered to Congress on July 31, at the same time that it notified lawmakers that it intended to regulate LDTs. What the FDA cannot discuss about LDT regulation, our experts can, and will."

This webinar, entitled  "FDA Prepares to Regulate LDTs: What You Must Know, What Your Lab May Need to Do, and Why You Should Prepare Now" is being presented on Wednesday, September 17, 2014 at 1:00 PM EDT. The respected hosts of this web conference not only have their fingers on the pulse of the lab testing industry, they
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SOURCE The Dark Report
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