
FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Roche experts discuss the company’s recently launched automated solution and how it will bring mass spec to more patients