OCP reports specific activities and impacts in this section. Much of the workload data were obtained through the use of an internal database for documenting OCP’s activities and e-mail records. The following summary illustrates the scope and breadth of OCP activities throughout FY 2008.
- Documented approximately 560 OCP activities in FY 2008.2 These documented records included 380 activities conducted with stakeholders external to FDA and 180 with internal stakeholders. As provided further in this section, the topics of the contacts included jurisdiction/classification assignments (190 contacts); premarket review issues (359 contacts); and postmarket regulation issues (40 contacts).
2 These activities are in addition to a wide range of OCP activities associated with its monitoring of the intercenter consults and its review of and response to RFD. Additionally, some of the reported activities may have involved more than one activity and may be represented in multiple topics.
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