FDA commissioner steps down in March | Pharmafile

Read the full article: FDA commissioner steps down in March | Pharmafile:

"The commissioner of the US Food and Drug Administration Dr Margaret Hamburg is to resign from her post in March according to unconfirmed reports.

Hamburg who has been leading the agency for almost six years, is set to be temporarily replaced by the US regulator’s chief scientist Stephen Ostroff until a permanent replacement is found, all of which is set to be officially announced tomorrow by the White House."

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We Moved Forward on Many Fronts This Year | FDA Voice

Commisioner of the United States Food and Drug Administration Margaret Hamburg. (Photo credit: Wikipedia)

We Moved Forward on Many Fronts This Year | FDA Voice:

"All of us take great pride in the skill and vigor with which we overcame the year’s challenges and new demands. And so, as the year draws to a close, I extend my gratitude to the employees at the FDA who work tirelessly on behalf of the American public year in and year out. To all of our stakeholders, my heartfelt wishes for a joyous holiday season and a safe and healthy 2014.

Margaret A. Hamburg, M.D., is the Commissioner of the Food and Drug Administration"

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FDA Asked About Mobile Apps and the FDA 510K Process

Congress asks FDA if “actual use” is factor in medical app regulation | mobihealthnews:

". . . The letter also asks whether the FDA will consider the “actual use” of a mobile medical app in addition to the “intended use” when making its determination about whether an app needs to go through the 510(K) process. Finally, the letter closes with a series of questions related to the final guidance document and the committee wants answers by March 15th."

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Read the Letter Sent to FDA Commissioner Margaret Hamburg (pdf)

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