Target Selection: The Universal Challenge A never-ending challenge for companies that develop IVDs, LDTs, and RUO products is identifying the most marketable biomarkers, both to guide sales and marketing strategies for existing products, and to guide investment in the...
Five U.S. Senators have signed a letter urging the Office of Management and Budget (OMB) to released a draft guidance on LDT regulation. OMB apparently has 90 days to review regulatory policies but has held the FDA’s draft guidance on LDTs “for several...
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