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CBER Reorganization Poses “Significant” Staff Retention Issues – Zoon

This article was originally published in The Gray Sheet

Executive Summary

The reorganization of FDA's Center for Biologics Evaluation & Research poses a significant problem for employee retention, Director Kathryn Zoon told the FDA Science Board Oct. 25

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CBER staff changes

Sixty-three of 213 CBER Office of Therapeutic Research & Review FTEs are reassigned to CBER's Office of Cellular Tissue & Gene Therapies, while the remaining FTEs will be transferred to the drug center, FDA reports. The Jan. 8 agency memo details phase two of a three-part plan to shift review of biologic therapeutic products to the Center for Drug Evaluation & Research. The restructuring was announced last fall (1"The Gray Sheet" Nov. 22, 2002, p.11)...

CBER staff changes

Sixty-three of 213 CBER Office of Therapeutic Research & Review FTEs are reassigned to CBER's Office of Cellular Tissue & Gene Therapies, while the remaining FTEs will be transferred to the drug center, FDA reports. The Jan. 8 agency memo details phase two of a three-part plan to shift review of biologic therapeutic products to the Center for Drug Evaluation & Research. The restructuring was announced last fall (1"The Gray Sheet" Nov. 22, 2002, p.11)...

CBER Deputy Director Goodman To Assume Biologics Directorship In January

Incoming Center for Biologics Evaluation & Research Director Jesse Goodman, MD, brings a working relationship with blood test manufacturers from his experience as CBER deputy director

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