OCP is required to resolve disputes regarding the timeliness of the premarket review of a combination product. OCP FY 2008 activities and impacts related to the effective resolution of review disputes are as follows:
- Facilitated the resolution of issues presented informally by sponsors concerning the timeliness of premarket review of combination products. OCP facilitated communications between sponsors and FDA review staffs to identify, clarify, and resolve specific concerns associated with review timeliness. These activities help prevent the need for more formal dispute resolution. OCP received no formal dispute resolution requests in FY 2008.
Next page: Additional Activities and Impacts