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Lawmakers Press OMB To Release Lab-Developed Test Draft Guidance

In a letter to Office of Management and Budget director Sylvia Mathews, nine Democratic representatives urged the release of a draft guidance establishing an FDA oversight structure for laboratory-developed tests. FDA said more than a year ago that the documents were under administrative review.

It was 2010 when FDA announced its plans to establish a comprehensive regulatory framework for laboratory-developed tests. Some congressional members are now getting impatient for a draft version of the framework.

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