  Joanne Less has become the acting director of the US Food  and Drug Administration’s Office of Combination Products (OCP). Less replaces  Mark Kramer, who recently resigned as FDA’s director of the OCP. Less is currently the associate director for  clinical research and government affairs in the Center for Devices and  Radiological Health and is that Center’s expert on the laws, regulations, and  policies governing the clinical investigation of medical devices, particularly  those related to human subject protection. 

Jim Shugars has been named the director for the Office of  Information Technology, CDER (OIT–CDER). Jim will report to the FDA CIO and  manage the IT staff that supports CDER. Jim has served as acting director for  OIT-CDER for over a year. Jim works with a wide range of government and  contract personnel in defining, developing, and implementing automated systems. 

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Joanne Less has become the acting director of the US Food and Drug Administration's Office of Combination Products (OCP).