Lawmakers Press OMB To Release Lab-Developed Test Draft Guidance
This article was originally published in The Gray Sheet
Executive Summary
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to Office of Management and Budget director Sylvia Mathews, nine Democratic representatives urged the release of a draft guidance establishing an FDA oversight structure for laboratory-developed tests.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.
You may also be interested in...
Senators Push OMB For Lab-Developed Test Guidance, Academic Labs Resist
Several Democratic Senators want the Office of Management and Budget to release the FDA draft guidance on lab-developed tests that has been stuck at OMB for years. Academic clinical labs send their own letter to the budget office, pleading that the guidance not be released.
Senators Push OMB For Lab-Developed Test Guidance, Academic Labs Resist
Several Democratic Senators want the Office of Management and Budget to release the FDA draft guidance on lab-developed tests that has been stuck at OMB for years. Academic clinical labs send their own letter to the budget office, pleading that the guidance not be released.
FDA Approves First Next-Generation DNA Sequencing Platforms
Illumina’s MiSeqDx instrument and MiSeqDx Universal Kit, granted de novo approval, allow clinicians to “develop and validate sequencing of any part of a patient’s genome,” FDA says.