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FDA's Threat of Lab-Developed Test Oversight Is Back on the Table with Proposed Rule

On October 3, 2023, the U.S. Food and Drug Administration (FDA) published a proposed rule to regulate laboratory-developed tests (LDTs). The rule, if finalized, would amend FDA regulations to broaden the definition of “in...more

Wilson Sonsini Digest of FDA Actions Related to COVID-19

Many global markets have been impacted by COVID-19, including the medical product and food industries. Both sectors are particularly critical as medical products are relied upon to help abate the disease and as communities...more

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