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FDA pushes forward with plans to regulate laboratory-developed tests in a move that will impact many clinical laboratory companies and pathology groups

from DARK Daily

From Sept. 9: After sitting in a state of suspended animation for several years, the Food and Drug Administration's plans to regulate laboratory-developed tests are now front and center. On July 31, the FDA served the required 60-day legal notice to Congress that it was ready to move forward to issue rules for regulation of laboratory-developed tests. more


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