Jan 5, 2011
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.
A new study sponsored by the US medical device industry trade association Advanced Medical Technology Association (AdvaMed), “EU Medical Device Approval Safety Assessment,” has found that the European regulatory system has performed just as effectively in terms of public safety as the US Food and Drug Administration while simultaneously providing a speedier and more efficient path to market for manufacturers.
A final FDA rule affecting ventricular bypass devices, pacemaker repair or replacement material
The US Food and Drug Administration has extended its comment period to November 28, 2011 for guidance the agency issued