FDA Plans Boost in Lab Capacity and Staff

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.”