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CDER Compliance Office Head Horowitz Is Former Associate Chief Counsel

Executive Summary

The Center for Drug Evaluation & Research Office of Compliance will be led by a director with experience in litigation and policy development rather than a background in the field offices.

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Office of Compliance appoints policy director

Deborah Autor named CDER Office of Compliance Associate Director for Compliance Policy; she was Department of Justice lead counsel in the case that won FDA its right to collect "disgorgement fees" for GMP violations (1"The Pink Sheet" Oct. 23, 2000, p. 4). In her newly created position, Autor reports to Office of Compliance Acting Director David Horowitz...

Office of Compliance appoints policy director

Deborah Autor named CDER Office of Compliance Associate Director for Compliance Policy; she was Department of Justice lead counsel in the case that won FDA its right to collect "disgorgement fees" for GMP violations (1"The Pink Sheet" Oct. 23, 2000, p. 4). In her newly created position, Autor reports to Office of Compliance Acting Director David Horowitz...

Wyeth Will Lose 18.5% Of Marietta Sales If Firm Does Not Comply With GMPs

Wyeth-Ayerst would have to pay the government 18.5% of future net sales from products manufactured at its Marietta, Penn. facility if it fails to meet a timeline for bringing the plant into compliance with current Good Manufacturing Practices under an Oct. 3 consent decree with FDA.

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