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Clinical Trials Clinical Laboratories Federal Food Drug and Cosmetic Act (FFDCA)

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First salvo fired against FDA’s laboratory developed test rule

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In the Eastern District of Texas U.S. federal court, the American Clinical Laboratory Association (ACLA) and its member company, HealthTrackRx, have filed a lawsuit against the Food and Drug Administration (FDA), claiming the...more

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FDA authority to conduct bioresearch monitoring inspections expanded by appropriations legislation

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U.S. President Biden recently enacted the “Consolidated Appropriations Act, 2023,” a $1.7 trillion omnibus funding bill that contains the Food and Drug Omnibus Reform Act (FDORA). Below we analyze how Section 3612 of FDORA,...more

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