Where can I find a summary of yearly OCP activities?
OCP’s most recent Report to Congress summarizes OCP’s activities and impacts. Much of OCP’s work is also posted on the Combination Products Website. In addition, the Office is currently developing guidance for adverse event reporting and for determining the appropriate number of marketing applications for combination products. We are also working to finalize guidance documents and regulations previously issued in draft form. Stakeholders have identified a number of other important issues that OCP will need to address, such as handling of post-approval changes, labeling format, registration and listing, and promotion and advertising. The Office will also evaluate the impact of the new policies, as well as the need for revisions or legislative changes. OCP is committed to continuing to seek input from stakeholders on its activities.
