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Thanks for your post, Hank. NDI needs to be on the front burner so that after the elections we are not suddenly taken by surprise. The FDA was not "empowered" to re-interpret the law it was given by the American people through Congress to regulate, but it did go ahead and do that anyway. Plus, FDA is already citing this "informal" Guidance as if it were already finalized.</p>
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jamesgormley
