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FDA Finalizes LDT Regulation, with Significant Exceptions: Enforcement of Requirements Will Phase In over Four Years | Akin Gump Strauss Hauer & Feld LLP

On April 29, 2024, the Office of the Federal Register placed on display the Food and Drug Administration’s (FDA) final rule on the regulation of laboratory developed tests (LDTs). Set. ....

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FDA pilots oncology companion diagnostic test/device program as LDT rulemaking nears

The U.S. Food and Drug Administration recently released the guidance “Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot… ....

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FDA Opens a Pilot Program to Scrutinize Certain Laboratory Developed Tests, But Will It Generate Sufficient Interest? | Mintz

The U.S. Food and Drug Administration (FDA) announced a new pilot program on June 21, 2023 that gives sponsors of oncology products the opportunity to submit validation and performance. ....

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FDA New Pilot Program For Laboratory Developed Tests

Food and Drug Administration officials have made public statements regarding the agency’s intent to promulgate new regulations for LDTs through the NPRM process ....

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FDA Launches Pilot Program to Help Reduce Risks Associated with Using Laboratory Developed Tests to Identify Cancer Biomarkers

/PRNewswire/ Today, the U.S. Food and Drug Administration announced a new voluntary pilot program for certain oncology drug products used with certain. ....

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