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Statutory Interpretation › Laboratory Developed Tests › Loper Bright Enterprises v Raimondo

Foley Hoag LLP

Loper Bright's Implications for the Food and Drug Administration and Regulated Industry

Foley Hoag LLP on

Under the Chevron doctrine, FDA and other agencies had significant flexibility to set policy where Congress left a gap or failed to speak clearly when enacting legislation—a common occurrence given the at-times sparse...more

Mintz - Health Care Viewpoints

Five Observations from FDA’s Responses to Comments in the Final Rule on LDTs

Mintz - Health Care Viewpoints on

Now that the final rule on laboratory developed tests (LDTs) has been available for over a month and the stages of the enforcement discretion phaseout process and the Food and Drug Administration’s (FDA’s) newly proposed...more

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