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What’s in the FDA Final Rule Regulating Laboratory-Developed Tests as Medical Devices?

Our FDA/Food, Drug & Device Team analyzes the practical considerations for adhering to the Food and Drug Administration’s final rule for laboratory-developed tests (LDTs)....more

FDA Continues to Accelerate Availability of COVID-19 Tests

The Food and Drug Administration (FDA) is racing to make coronavirus tests more widely available. Our Food, Drug & Device/FDA Team examines how the FDA is using its authority to issue emergency use authorizations (EUAs) to...more

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