US EditionFederal judge nixes FDA’s LDT rule, says agency exceeded its authority - The Cancer Letter
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Federal judge nixes FDA’s LDT rule, says agency exceeded its authority - The Cancer Letter
A federal judge ruled that the FDA lacks the statutory authority to regulate laboratory developed tests, finding squarely in favor of plaintiffs in the consolidated lawsuits brought by American Clinical Laboratories Association, Association for Molecular Pathology, and others. ASCP submitted an amicus brief supporting the plaintiffs. This content is for Group 1 - Individual Seat, Individual Subscription - Annual ($555), Individual Subscription …
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