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Published: November 4, 2011
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Senators, Clinicians, and Type-1 Diabetics Continue to Pressure FDA on Artificial Pancreas Guidance


On November 2, 2011, a group of U.S. Senators, medical professionals, and people suffering from Type 1 diabetes pressed FDA to develop reasonable guidance on the artificial pancreas. A petition to FDA already has 100,000 signatures, reports a press release from the Juvenile Diabetes Research Foundation (JDRF).

As MD+DI explained in a previous article describing support of the artificial pancreas, nearly 3 million people in the United States have Type 1 diabetes.

“The FDA has a real opportunity not only to foster innovation but also to help diabetes patients in the United States by issuing the draft guidance on time and by taking into serious account the scientific consensus on the safest and most rapid way forward,” said Senator Susan Collins (R-ME) in the aforementioned press release.

The call for FDA to swiftly approve innovative products seems to almost be a rallying cry lately. Recently, the device industry seems to especially concerned about FDA’s possible plans to require more information about “the effectiveness of complex medical devices before approving them.”

FDA had promised earlier to release guidance concerning the artificial pancreas by December 1, 2011. “For the good of those families dealing with this disease, the FDA must honor that commitment,” said Senator Jeanne Shaheen (D-NH) in a statement.

—Brian Buntz


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