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Torti Memo To FDA Staff: Transparency Tempered By Confidentiality Duties

This article was originally published in The Gray Sheet

Executive Summary

FDA is committed to transparency and "the principles of open government," FDA Acting Commissioner Frank Torti says in a memo distributed to agency staff March 13. But that is the opening qualifier to a cautionary note that employees must comply with obligations to keep certain information "confidential.

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Regulatory News In Brief

FDA guard change: Acting FDA Commissioner Frank Torti will leave the agency April 4 to return to Wake Forest University School of Medicine, and incoming principal deputy commissioner-pick Joshua Sharfstein will assume the acting commissioner role on March 30, FDA staffers were informed in a March 27 memo. Torti joined FDA in May 2008 as the agency's first chief scientist and has served as acting commissioner since Andrew von Eschenbach left FDA on Jan. 20. Torti will resume his former role at Wake Forest as chair of the department of cancer biology and director of the Comprehensive Cancer Center; he also will assume the new role of VP-strategic programs. Sharfstein, who does not need Senate confirmation to take the deputy job, will be acting commissioner until confirmation of commissioner nominee Margaret Hamburg (1"The Gray Sheet" March 23, 2009, p. 3)

Regulatory News In Brief

FDA guard change: Acting FDA Commissioner Frank Torti will leave the agency April 4 to return to Wake Forest University School of Medicine, and incoming principal deputy commissioner-pick Joshua Sharfstein will assume the acting commissioner role on March 30, FDA staffers were informed in a March 27 memo. Torti joined FDA in May 2008 as the agency's first chief scientist and has served as acting commissioner since Andrew von Eschenbach left FDA on Jan. 20. Torti will resume his former role at Wake Forest as chair of the department of cancer biology and director of the Comprehensive Cancer Center; he also will assume the new role of VP-strategic programs. Sharfstein, who does not need Senate confirmation to take the deputy job, will be acting commissioner until confirmation of commissioner nominee Margaret Hamburg (1"The Gray Sheet" March 23, 2009, p. 3)

Device Center Discord: 510(k) Review Process Is Flash Point At CDRH

Details trickling into the public sphere about CDRH's device review process reveal heightened tension between reviewers and management over the proper response to a 510(k) submission

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