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Navigating the Future of Laboratory Developed Tests - The Impact of New FDA Guidance

By Nicholas Smith

Uncertainty and concern best describe the prevailing feelings of many researchers, clinicians, and companies that develop, manufacture, and implement laboratory developed tests (LDTs). The reason for all this uncertainty is the U.S. Food and Drug Administration's (FDA) stated plan to issue a new guidance that would change the paradigm for regulating LDTs.

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