A federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May of last year, which said laboratory-developed ...
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Judge foils FDA plan to regulate lab-developed tests
Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could guide their treatment when commercial tests don’t exist or aren’t precise ...
On August 19th, the Association for Molecular Pathology (AMP), and pathologist Michael Laposata, MD, Ph.D., filed a lawsuit challenging the recent U.S. Food and Drug Administration (FDA) Rule that ...
A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices in a victory for the clinical lab industry. Judge Sean ...
ROCKVILLE, Md. – March 31, 2025 – The Association for Molecular Pathology, the premier global molecular diagnostic professional society, and pathologist Michael Laposata , M.D. , Ph.D., today ...
WASHINGTON, Sept. 5, 2024 /PRNewswire/ -- Today, the Association for Diagnostics & Laboratory Medicine (ADLM, formerly AACC) released the latest results from an ongoing survey that ADLM has been ...
Many doctors and laboratories don't have the resources to comply with the Food and Drug Administration’s final rule on the regulation of laboratory developed tests and will likely scale back the ...
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