Consolidation of CBER and CDER Reviews
Published: March 2nd, 2003
FDA has announced that nearly $32.9 million will be transferred from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). This move is part of the effort to consolidate reviews of certain therapeutic biologic products and their packaging within CDER.
The funds represent 208 full-time equivalent (FTE) positions from CBER and five FTEs from FDA's field operations. They also include eight brand-new FTEs proposed for the fiscal year 2003 budget.
The product categories being transferred include monoclonal antibodies, proteins extracted from animals or microorganisms (but not human blood), cytokines, growth factors, enzymes, and interferons, but only those intended for therapeutic use.
Reviews of therapeutic vaccines and their packaging and delivery systems will remain in CBER.
At press time, the agency's working group on the consolidation was beginning to work on the logistics of the transfer, including developing procedures and timelines for transfer of individual products.
Consolidation of CBER and CDER Reviews
by Erik Swain, Senior Editor
FDA has announced that nearly $32.9 million will be transferred from the Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). This move is part of the effort to consolidate reviews of certain therapeutic biologic products and their packaging within CDER.
The funds represent 208 full-time equivalent (FTE) positions from CBER and five FTEs from FDA's field operations. They also include eight brand-new FTEs proposed for the fiscal year 2003 budget.
The product categories being transferred include monoclonal antibodies, proteins extracted from animals or microorganisms (but not human blood), cytokines, growth factors, enzymes, and interferons, but only those intended for therapeutic use.
Reviews of therapeutic vaccines and their packaging and delivery systems will remain in CBER.
At press time, the agency's working group on the consolidation was beginning to work on the logistics of the transfer, including developing procedures and timelines for transfer of individual products.
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