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Lab Stakeholders Still Oppose FDA’s Multivariate Assay Policy

This article was originally published in The Gray Sheet

Executive Summary

Laboratories are urging FDA to once again rework, if not abandon, its proposal to actively regulate certain lab-developed tests, while diagnostics companies are split on the issue

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Lab Group Urges FDA To Wait For Congress On LDT Issue

Jeff Shuren recently spoke at the annual American Clinical Laboratory Association industry meeting where the device center director was grilled on FDA's plans to regulate lab-developed tests. While ACLA President Alan Mertz appreciates Shuren's willingness to engage, his group continues to push back hard against the agency's plan to move forward with a final LDT plan before Congress has a chance to act.

FDA Aims To Finalize Framework For Lab-Developed Tests In Near Term

FDA could have a final framework in place for overseeing a greatly expanded range of laboratory test services within months of a public meeting scheduled for July, according to agency officials

FDA Aims To Finalize Framework For Lab-Developed Tests In Near Term

FDA could have a final framework in place for overseeing a greatly expanded range of laboratory test services within months of a public meeting scheduled for July, according to agency officials

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