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FDA wary of impact of retirements on inspectional activities

The U.S. FDA’s senior managers often lament the lack of routine increases in taxpayer funding, a concern that Michael Rogers, the associate FDA commissioner for regulatory affairs, reiterated during a May 1 webinar. Rogers said the agency’s field inspectorate will be working through a large number of retirements over the next few years, a predicament he said will continue to be “a huge challenge” to overcome. ....

Michael Rogers , Bioworld Medtech , Fda Office Of Regulatory Affairs , Fda Ora , Fda Oii , Alliance Fora Stronger Fda ,

US FDA says reorganization a tough slog in tight budgetary environment

The U.S. FDA is undergoing a significant overhaul of operations which is designed in part to make the agency’s Office of Regulatory Affairs (ORA) more efficient and less obtrusive to product centers, such as the Center for Devices and Radiological Health. ....

Radiological Health , Office Of Regulatory Affairs , Regulatory Affairs , Bioworld Medtech , Alliance Fora Stronger Fda ,