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BioCentury
ARTICLE | Regulation

After pushing FDA out of and back into COVID-19 LDT review, HHS turns to outsourcing

By  Karen Tkach Tuzman, Senior Editor
January 14, 2021 12:43 AM UTC

HHS is dealing with the fallout of its deregulatory push for COVID-19 lab tests by leaning on ex-FDA consultants for EUA reviews.

The consulting and CDO firm NDA Partners, a subsidiary of The Planet Group (TPG), announced Tuesday it had been awarded a government contract to conduct reviews of laboratory developed tests (LDTs) to detect COVID-19, including tests that also detect other respiratory pathogens. ...

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