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FDA LDT Regulation

FDA LDT Regulation
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FDA's Proposed Rule on LDT Regulation and the Debate over Agency Deference | Sheppard Mullin Richter & Hampton LLP

Earlier this month, the Food and Drug Administration (“FDA” or “the Agency”) issued a highly anticipated proposed rule outlining the regulatory framework and implementation plan for. ....

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FDA Roundup: October 17, 2023

FDA Roundup: October 17, 2023
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FDA Roundup: October 17, 2023

/PRNewswire/ Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA s The Center. ....

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FDA Signals Intent To Regulate Lab Developed Tests

Pacific Edge notes the U.S. Food and Drug Administration (FDA) has released for public comment proposed rule changes that seek to have Laboratory Developed Tests (LDTs) such as Cxbladder regulated as medical devices under the US Federal Food, . ....

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