LDTs
The ruling makes clear that the FDA lacks the legal authority to regulate LDTs, and observers suggest it could also call into question its authority in other areas.
Federal Court Vacates FDA Rule on Laboratory-Developed Tests
The ruling prevents the FDA rule on LDTs, which is opposed by much of the clinical lab industry and many segments of the broader healthcare industry, from going into effect.
Under Constant Fear of Job Loss, FDA Reviewers Worry About Ensuring Diagnostic Efficacy, Safety
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One reviewer described having to look through thousands of lines of data on IVDs with the "sword of Damocles" hanging over their head.
The firm is developing prognostic cancer tests targeting "master driver" genes that control cancer-related biological pathways.
Association for Molecular Pathology 'In Limbo' as FDA Lawsuit Moves Ahead, LDT Regulations Loom
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At the AMP annual meeting this week, leadership briefed members on what to expect as its lawsuit challenging the FDA final rule on laboratory-developed test regulation unfolds.