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FDA Watch: How Could the End of Chevron Impact the FDA and LDTs?
A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes
A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
UK-developed assay that uses a sponge appears to reduce the need for more invasive endoscopies.