Five U.S. Senators have signed a letter urging the Office of Management and Budget (OMB) to released a draft guidance on LDT regulation. OMB apparently has 90 days to review regulatory policies but has held the FDA’s draft guidance on LDTs “for several...
FDA’s warnings to 23andMe illustrate some of the major problems with current regulation of diagnostic tests. 23andMe uses a CLIA-certified lab to perform its test and so is within its rights, like all CLIA labs, to offer a test developed and run in its own lab...
Margaret Hamburg took the opportunity, at the end of a speech honoring a colleague at the annual meeting of the American Society of Clinical Oncology (ASCO), to make some pointed comments that should make LDT developers every more concerned about impending regulation...
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