The New York Times reports that a series of emails show how Department of Health and Human Services officials sought to silence the Centers for Disease Control and Prevention.
Politico reports that political appointees are interfering with what appears in the Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Reports.
The community is poised to be the primary channel for stakeholders to communicate PGx concerns with FDA, but it is unclear if all stakeholders will participate.
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
CNN reports the change in the US Centers for Disease Control and Prevention's coronavirus testing guidelines was in response to administration pressure.
The action will immediately allow labs to offer SARS-CoV-2 LDTs without requiring EUA, and make it voluntary for labs to take LDTs through FDA premarket review.
