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President Obama on FDA regulatory structure, in plain English

by Jeffrey Clark on January 24, 2012

Just days ago, President Obama authored an article in the Wall Street Journal entitled, Toward a 21st-Century Regulatory System.

While not wholly specific to the life sciences industry, he does address government regulatory process in general as inefficient and makes several inferences to the FDA.  As relates to medical devices and the much wrangled 510(k) process, Obama writes, “Tomorrow the FDA will lay out a new effort to improve the process for approving medical devices, to keep patients safer while getting innovative and life-saving products to market faster.”

So what did the FDA release?  Well, it’s not as plain spoken and straightforward as the President’s intent.  You can find it here.

Wall Street Journal

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