Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration (FDA) and its regulatory oversight for medical device ...
The year 2009 is remembered in medtech regulatory circles as the year in which long-simmering turmoil erupted into the open at FDA's Center for Devices and Radiological Health (CDRH). It cost Daniel ...
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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