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FDA Watch: Next-Gen Sequencing Companion Test Wins Approval

by | Dec 29, 2016

Last month, the U.S. Food and Drug Administration shelved its longawaited/ dreaded (depending on your point of view) final guidance on laboratory-developed tests. (For the details, see, LIR, Nov. 2016). This month, it was back to business as usual—although a piece of significant new legislation will have a lasting impact on the FDA in the […]

Last month, the U.S. Food and Drug Administration shelved its longawaited/ dreaded (depending on your point of view) final guidance on laboratory-developed tests. (For the details, see, LIR, Nov. 2016). This month, it was back to business as usual—although a piece of significant new legislation will have a lasting impact on the FDA in the […]

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