Regulatory expectations for medical device risk management are evolving toward the need for “mature” systems and processes. Recent standard revisions also emphasize patient safety -...
Sharfstein Out at FDA
The FDA’s second-in-command Joshua Sharfstein is stepping down as principal deputy commissioner to become Maryland’s secretary of health and mental hygiene, according to The Washington Post.
Sharfstein’s resignation comes less than two years after the Obama Administration appointed him to lead its FDA transition team. Under the direction of Sharfstein and FDA Commissioner Margaret Hamburg, the agency reviewed its drug and medical device review processes and increased enforcement efforts in order to distance itself from Bush-era accusations of overly accommodating relationships with the industries it oversees, according to the Post.
Sharfstein's successor at the FDA has yet to be named.
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