This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
News|Articles|May 8, 2008
FDA Plans Boost in Lab Capacity and Staff
Author(s)Pharmaceutical Technology Editors
To keep pace with proposed increases in the number of manufacturing inspections, the US Food and Drug Administration's Office of Regulatory Affairs (ORA) has announced it will increase laboratory capacity and staff.
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Rockville, MD (Apr. 28)-To keep pace with proposed increases in the number of manufacturing inspections, the US Food and Drug Administration’s Office of Regulatory Affairs (ORA) has announced it will increase laboratory capacity and staff.
Margaret Glavin, associate commissioner for regulatory affairs, told ORA employees in an internal agency memorandum (according to Drug Industry Daily) “the focus of CDER over the next five years is to increase the number of inspections based on anticipated advances in manufacturing technologies. We must ensure that we have the proper analytical disciplines, equipment, and processes in place.”
Additional inspections are anticipated as industry and various organizations announce support for the
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