PALO ALTO, California, October 13, 2011 -- In the September 2011 issue of the Food and Drug Law Journal, Baker Botts L.L.P. lawyer Matt Avery co-authored the article ‘Bringing Smart Pills to Market: FDA Regulation of Ingestible Drug/Device Combination Products’ with Dr. Dan Liu of U.C. Hastings.
The article examines regulation of ingestible drug/device combination products by the Food and Drug Administration. These so-called “smart pills” are a emerging type of medical therapy. However, this nascent technology has yet to reach the market and developers of these novel therapies face significant regulatory challenges.
This article predicts how the FDA will regulate smart pills and shows how the current regulatory regime is inadequate. The article then proposes modifying the current regulatory regime to encourage development of smart pills and other innovative combination products by: (1) regulating combination products based on their “novel mode of action” rather than their “primary mode of action,” (2) creating a marketing approval pathway specifically for combination products, and (3) eliminating regulations that require sponsors to get marketing approval from multiple centers within FDA and providing regulatory guidance specifically for ingestible drug/device combination products.
To view the complete Food and Drug Law Journal article, please click here.
Matt Avery’s bio is available here.
This article is posted with the permission of FDLI.
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