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FDA Enforcement Office Director Niedelman Brings CDRH Background To Post

Executive Summary

The FDA Office of Enforcement's transition to "risk-based" good manufacturing practices oversight will be led by an FDAer with more than two decades of experience in medical device manufacturing regulation

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FDA Regulatory Affairs

FDA Office of Enforcement Acting Director Steven Niedelman will become assistant commissioner for regulatory affairs, a new position, as of Dec. 1. Niedelman has been acting head of enforcement since September, after joining the office as deputy director in July 2001 (1"The Pink Sheet" Sept. 16, p. 23). He previously spent 24 years in the Center for Devices & Radiologic Health's compliance office. Niedelman will continue to report to Associate Commissioner for Regulatory Affairs John Taylor...

FDA Regulatory Affairs

FDA Office of Enforcement Acting Director Steven Niedelman will become assistant commissioner for regulatory affairs, a new position, as of Dec. 1. Niedelman has been acting head of enforcement since September, after joining the office as deputy director in July 2001 (1"The Pink Sheet" Sept. 16, p. 23). He previously spent 24 years in the Center for Devices & Radiologic Health's compliance office. Niedelman will continue to report to Associate Commissioner for Regulatory Affairs John Taylor...

FDA GMP Plan Stresses Consistency; Systems Approach Ratified By Crawford

FDA will work with an outside consultant to help increase the consistency of pre-approval and post-approval manufacturing oversight

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