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Wilson Sonsini Goodrich & Rosati

FDA Signals to Industry to Prepare for Compliance with the LDT Final Rule Despite Looming Legal Challenge

Wilson Sonsini Goodrich & Rosati on

The U.S. Food and Drug Administration (FDA) is reaffirming its plans to actively regulate certain laboratory developed tests (LDTs) that the FDA has historically treated with enforcement discretion. On June 25, 2024, the FDA...more

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