R egulators at the Food and Drug Administration told STAT the firm’s decision this month to halt a prominent, Costs Gates-backed effort to study the spread of coronavirus in the Seattle area followed the researchers involved stopped working to protect required approval.
The program, called the Seattle Coronavirus Evaluation Network, or SCAN, was initially focused on studying the flu however rapidly rotated to track the coronavirus at the start of the pandemic, making inroads in tracking the spread of the virus and bring in prominent support from companies like shipping giant Amazon, whose health care arm got and provided Covid-19 tests to healthy and contaminated individuals. The FDA stopped the effort all of a sudden last week, the New York Times reported
The study did not have two type of clearance from the agency, the FDA said: a federal emergency use authorization, a kind of pandemic-era green light used to speedily clear tests and medical devices during an emergency situation, and approval from an outside group of experts charged with offering ethical oversight for research study, referred to as an institutional evaluation board. Obtaining either clearance might have permitted the effort to go forward, according to the FDA.
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Outdoors specialists decried FDA’s choice, saying the abrupt relocation was unnecessary, confusing, and counterproductive. Rather than shutting down the SCAN effort, the company could have asked them to re-apply for approval from the ethics board.
” The FDA’s position here is illogical,” said Eric Topol, director of the Scripps Research Study Translational Institute, which is likewise tracking the spread of coronavirus “If they really want