2024: Year of Decision for FDA Regulation of LDTs

FOR OFFICIALS AT THE FEDERAL FOOD AND DRUG ADMINISTRATION (FDA), it’s been a long road to gain the power to regulate laboratory-developed tests (LDTs). It was in 2014 when the FDA sent a notice to Congress of its intention to begin regulation of LDTs. In the decade since, there has been continuing debate about whether …

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2024: Year of Decision for FDA Regulation of LDTs

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