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Healthcare › Laboratory Developed Tests › Rulemaking Process

Polsinelli

Challenges to LDT Final Rule Continue as Rule Goes into Effect

Polsinelli on

As discussed in our May 6, 2024, Client Alert, earlier this year FDA issued its Final Rule for the regulation of laboratory-developed tests (LDTs) that the FDA has historically treated with enforcement discretion. A week...more

Akin Gump Strauss Hauer & Feld LLP

The Regulatory Race Is On: The Biden Administration Sprints to Issue Key Health Policies

Akin Gump Strauss Hauer & Feld LLP on

The upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...more

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