FDA Will Take Time to Digest Comments on LDT Guidance, Says Liz Mansfield


Liz Mansfield, Deputy Office Director of Personalized Medicine, OIR, FDA

Bio and Contact Info


Listen (6:39) The timeline for LDT regulation

Listen (3:40) Could new guidance lead to fewer and lower quality tests?

Listen (2:55) FDA has been dealing with tricky area of "off-label" promotion for many years

Listen (4:31) Was there anything new in the feedback?

Listen (3:45) Labs asking what is the device here

Listen (2:30) What does the first phase after final guidance look like?

Listen (1:54) Upcoming NGS workshop

We’re very pleased to have Liz Mansfield of the FDA on the program to finish up our current Special Report on LDTs Series. Liz is part of the team at the FDA working on the new guidance for the regulation of LDTs, and she was at the recent meeting the FDA held to receive community feedback.

Today we get into some of the details of that feedback. Did Liz and the FDA hear any new issues that they had not already considered? What about the BRAF testing that was mentioned in the meeting? Is there a risk that patients will lose access to some important tests?

In a recent interview in this series, Amy Miller of the Personalized Medicine Coalition urged the FDA to push out their timeline for guidance. In this very open and candid interview, Liz responds that there is no set date for final guidance. “We will take the time it requires to go through them [community comments], analyze them, and decide what we need to do in response and finalize the guidance,” she says. "There is no rush to do that."

Podcast sponsored by: This Month in Biotech - Coming January 30th!

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