Archive for October 10th, 2016

How to Determine a Combination Product’s Primary Mode of Action

Combination products raise distinct regulatory challenges because they comprise two or more regulated components. Depending on its constituent parts, your combination product may require a review by several agency centers at the U.S. Food and Drug Administration (FDA). The FDA will then designate one agency center as the lead agency center for your combination product. This center will oversee the pre-market review and regulation of your combination product as a whole. Read more »