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Latest From Vivus, Inc.

Status Quo At US FDA?

The news that the Biden Administration is considering asking Robert Califf to return as Commissioner of the US FDA is the latest twist in a most unusual transition process at the agency. But one message seems abundantly clear: the White House is perfectly happy with FDA as it is.

FDA Leadership

Potential For Califf’s Second Term As US FDA Commissioner Surprises, Excites Stakeholders

Many supporters believe Robert Califf checks all the boxes, but if nominated he would also face many familiar confirmation challenges.

FDA Leadership

FDA Clarifies Software Link In Abbott COVID-19 Lab Test Recall

The recall is related to the software’s mixing parameters, which may cause false positives if test samples contaminate each other.

Recalls Safety

Abbott COVID-19 Lab Test Recall Deemed High-Risk Class I

The recall is related to potential false positives that may occur if a genuine positive test sample overflows into an adjacent sample that would have otherwise tested negative.

Recalls Safety
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