FDA Assesses Overview of Combination Products

October 20, 2015
BioPharm International Editors

The agency gives an update on the regulation of combination medical products.

In a Oct. 15, 2015 blog post, Robert M. Califf, MD, FDA’s deputy commissioner for Medical Products and Tobacco, and Jill Hartzler Warner, JD, FDA’s associate commissioner for Special Medical Programs, presented the findings of a focus group study on FDA’s regulation of combination products. Combination products take drugs, devices, and/or biological products and either combine them chemically or physically or package them together to create a “combination product”.

The focus group found that regulation of these products is complicated by communication, policies, practices, and systems between the different centers within the agency. The review of combination products is done by multiple centers at the agency and is led by the medical product Center that “provides the product’s primary mode of action.” The Office of Combination Products oversees the regulation.

The blog post states that FDA will be working to clarify regulatory requirement and improve internal processes by issuing guidance for review of combination products; enhancing data access; improving the monitoring of inter-center consults; improving the maintenance of internal contact directories; and improving standard operating procedures. According to FDA, while some of these steps are already in place, others will be in place in the next year or so.

Source: FDA