
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
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
Pre-submission and Q-Submission meetings apparently have been halted, for now
The PCR-driven test provides results in about 20 minutes in non-laboratory settings
The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026