Managed Review Process Sheryl A. Kochman Deputy Director, DBA, OBRR, CBER September 15, 2009. Outline. Definitions Origin and Description of CBER’s Managed Review Process Milestones and Policy Steps and Timeline in Managed Review Process Review Completion. Definitions.
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“A Primer on CBER’s Regulatory Review Structure and Process,” Suzanne M. Sensabaugh*, in Drug Information Journal, Vol. 32, pp 1011-1030, 1998
* Ms. Sensabaugh worked in the Office of the Center Director of CBER at the time this was written and published
The process incorporates: