Platinum-Free Systemic Therapy in First-Line Metastatic Urothelial Carcinoma: Mirage or Oasis in the Platinum Desert? Cancer predictive or diagnostic assays, offered as Laboratory-Developed Tests ...
The onset of COVID-19 proved to be a real-time stress test of America’s clinical testing system. The experience exposed several flaws in the system that policymakers should address, specifically, ...
Laboratory Developed Tests (LDTs) are critical for diagnosing rare diseases and addressing unmet clinical needs. They are developed, manufactured, and used within a single licensed clinical laboratory ...
On October 3rd, the Food and Drug Administration (FDA) published its widely anticipated proposed rule on the regulation of laboratory developed tests (LDTs). Last year, Congress failed to pass the ...
After introducing a user fee reauthorization draft in May, the Senate recently added a new proposal that would revamp the Food and Drug Administration’s regulation of clinical tests and diagnostics.
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 ...
The Food and Drug Administration released a final rule on Monday strengthening its authority over laboratory developed tests (LDTs), advancing a policy that has drawn fierce opposition from healthcare ...
ROCKVILLE, Md. – August 19, 2024 – The Association for Molecular Pathology (AMP), the premier global molecular diagnostic professional society, and world-renowned pathologist Michael Laposata, MD, PhD ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results