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Final Rules › Judicial Review › Laboratory Developed Tests

Sheppard Mullin Richter & Hampton LLP

LDT Final Rule Series: Part 4 – Rule Overturned by Federal District Court

Sheppard Mullin Richter & Hampton LLP on

Last Monday, the U.S. District Court for the Eastern District of Texas (the “District Court”) issued a highly anticipated – and unsurprising – opinion invalidating the U.S. Food & Drug Administration’s (“FDA’s” or the...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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