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FDAAA Members Are Updated on Combination Products

April 8, 2016

Combination drugs/devices/diagnostic products are becoming increasingly more common. They enable patients to be treated and diagnosed with multiple products that are designed and approved to be used together.

Thirty FDAAA members joined Thinh Nguyen, Director, Office of Combination Products (OCP), and Barr Weiner, Associate Director for Policy, OCP, for a lively luncheon discussion on April 8 about FDA’s latest initiative in reviewing combination products.

Thinh and Barr gave a brief overview of OCP’s current activities and then discussed some of the major “hot topics” in combination products, including the formation of a new combination products policy council, implementing “lean process” mapping, improved reviewer training, and forthcoming guidances and regulations.

Thinh and Barr were extremely generous with their time and willingness to engage. Their participation underscores the ongoing close relationship between FDA and FDAAA.

A great combination: Barr Weiner, Associate Director for Policy, OCP (left) and Thinh Nguyen, Director, Office of Combination Products (OCP)(right), offered FDAAA members insight into the increasingly important future of combination products and the collaborative cross-center efforts the FDA is implementing to meet future opportunities. The lunch took place at Mrs. K’s Toll House in Silver Spring.


April 8, 2016
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