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FDA Report Card 2015: Guidances


It is NOT FDA's job to provide guidance—they don't know anything more than anyone else. It is the company's job to decide how to design, test, and label their device. It is FDA's job to make sure the company can support what they say. That is the way the system is designed to work. Regrettably, we have bred an industry full of sheep who don't what to think for themselves and want to be told by FDA what to do. For those of us who have been playing this game for 20+ years, it was not always this way.

—Michael Drues, PhD, president, Vascular Sciences

There are probably too many of these perpetual 'draft and not binding' documents, which do not have the 'force and effect of law'. Consequently, the effort at application can be very subjective unless there is documented agreement between the regulator and regulated.

Larry R. Pilot, attorney at law

I think this is one of the agency's greatest weaknesses right now. FDA typically develops a draft guidance with very little interaction with industry. Then, once a draft guidance is published, the agency will leave it in draft form and move on to the next project. That means most of the guidances out there were written with very little industry input. I think we need a new approach.

—Bradley Merrill Thompson, shareholder, Epstein Becker & Green           

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