LDT Appeal: Looking at the Legal Nuances Behind Potential FDA Actions Following Court Decision
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
Already a member? Log in here
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Already a member? Log in here
Bringing Clinical Mass Spectrometry into Routine Medical Laboratory Testing
Roche experts discuss the company’s recently launched automated solution and how it will bring mass spec to more patients
Already a member? Log in here
Reimbursement Top Challenge for Labs in 2025
ACLA president Susan Van Meter discusses some of the key issues labs faced in 2024, along with work to address these developments through 2025
Already a member? Log in here
Which Recent FDA Webinars Are Most Useful for the LDT Rule?
Regulatory expert Julie Ballard shares her thoughts on the most useful resources for labs as they get ready to comply with Stage 1
Already a member? Log in here