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Alexander Statement on FDA’s Decision to Delay Making Final Guidance on Lab-Developed Tests

NASHVILLE, Nov. 18 – Senate health committee Chairman Lamar Alexander (R-Tenn.) today made the following statement on the Food and Drug Administration’s announcement it will delay making final its guidance regarding lab-developed tests until the next administration:

“I am glad that the FDA has listened and will delay making final its current draft guidance that could have halted more than 60,000 lab-developed tests in their tracks, and will work with Congress and the new administration on next steps. These tests are essential to helping millions of Americans screen for and diagnose diseases and conditions and advancing the president’s Precision Medicine Initiative to find more tailored treatments and cures. It is important to get this right.”

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