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FDA Creates Combination Products Council

April 6, 2016
Pharmaceutical Technology Editors

The agency has announced the creation of the Combination Products Policy Council to address issues related to combination products.

In an FDAVoice blog, Nina L. Hunter, PhD, FDA’s associate director for science policy, and Rachel E. Sherman, MD, FDA’s associate deputy commissioner, both in the Office of Medical Products and Tobacco, announced the creation of the Combination Products Policy Council. The council, which will be a senior-level forum involving multiple FDA departments, will have “decisional authority on issues relating to combination products, cross-labeled products, and medical product classification.”

The nature of combination products makes for a complex situation with differences in regulatory requirements, standards, and review limitations. The council will be tasked with modernizing the inter-center consultation process and related aspects of combination product review. The council will also promote the development of combination products and cross-labeled products and address product classification issues as well as be involved in drafting guidance documents, publications, and blog posts on policy decisions.

“We are confident that the Council’s efforts will ensure transparency and consistency in our approach to combination product policy development and implementation, ultimately helping to ensure that innovative combination products marketed to the American people are safe, effective, and appropriately labeled. We look forward to providing updates about the Council, as well as additional modernization efforts in this important area,” said Hunter and Sherman in the blog post.

Source: FDA