Where can I find guidance for what kind of safety and effectiveness information is needed to support approval of a combination product?
The best approach would be to contact the lead Center review division to discuss this issue. In addition, by reviewing approval documentation for approved combination products (available on each of the Centers’ websites), you can often get insight into study design and related issues for products FDA has approved. You may also find useful an abbreviated table of guidance documents that we have posted on the OCP website at http://www.fda.gov/oc/combination/guidance.html.
