Sharfstein to ResignSharfstein to Resign

Sharfstein has only been at the agency for a short time. He joined as acting commissioner in March 2009. Under his leadership, along with Comisioner Margaret Hamburg, the agency has become  aggressive in regulatory matters, issuing more warning letters to companies for manufacturing and marketing violations with less negotiation time, according to the Wall Street Journal.

During his short time at FDA, Sharfstein has been an agent of change, particularly for safety and transparency of medical devices. He has been critical of the 510(k) process, spurred by the approval of Regen Biologics's Menaflex Collagen Scaffold, which critics say was politically motivated. The clearance for the device has since been rescinded and review and revision of the 510(k) process is underway.

No details yet on who might take his place.

—Heather Thompson