Employees at the Food and Drug Administration’s medical device center on Tuesday received notice that they would be cut amid massive layoffs at federal health agencies. The reductions included people ...
FDA published a proposed rule that would regulate IVDs, including LDTs, as medical devices, drastically altering the regulatory landscape for LDTs. The proposed rule would update the definition of ...
The newest controversy concerned a rule making from which commissioner Margaret Hamburg had to recuse herself due to a perception of possible conflict of interest—ironic, considering that she is the ...
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