Laboratory Developed Tests

News & Analysis as of

FDA Regulatory Update: FDA Commissioner Suggests that New LDT Regulations are Forthcoming; Laboratory Industry Challenges FDA’s...

On June 2, 2013, U.S. Food and Drug Administration (“FDA”) Commissioner Margaret Hamburg delivered a speech at the American Society of Clinical Oncology’s annual meeting, in which she explained that the FDA is in the process...more

FDA's Plan to Regulate LDTs

In a remarkable move, the Food and Drug Administration recently indicated that it plans to take new steps to regulate laboratory-developed tests (“LDTs”). FDA Commissioner Margaret Hamburg made the significant announcement...more

FDA Regulatory Update: Laboratory-Developed Tests Once Again Come Under FDA’s Microscope and Laboratory Industry Opposes

Laboratory-developed tests (“LDTs”) appear to be under FDA’s microscope once again. These tests, which include genetic tests, companion diagnostics, and genetic tests, are developed and performed by a laboratory and have been...more

FDA Regulation of Laboratory Developed Tests: Benefit or Unnecessary Burden?

The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more

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