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 [...]

Combination products present regulatory challenges because their constituent parts must be reviewed by more than one agency center. Under section 503(g)(1) of the Federal Food, Drug, and Cosmetic Act, combination products are assigned to a lead center based on their primary [...]

Understanding the science behind drug, biological and medical devices ensures that combination products are safe for the market. The Food and Drug Administration (FDA) needs to collaborate with the Center for Drug Evaluation and Research, [...]

Recent FDA reforms — such as the federal agency’s lean management model and new Combination Products Policy Council — plan to simplify combination product review. However, getting a medical device to market is still a [...]

In March, the FDA spearheaded a lean management model that will transform the combination product review process. Now, the federal agency has introduced a new committee that will address industry policy issues, a change that [...]

You need to decipher ever-complex guidelines and a labyrinth of legislation before you can get a combination product to market. Correct product labeling and training is no longer enough; your company requires comprehensive workflows to [...]