Monday, February 28, 2005

The FDA's need for speed

Lester Crawford's nomination to become the next commissioner of the U.S. Food and Drug Administration could be good news for nanotech companies and others who would like to see the agency put urgently needed drugs on the fast track to approval.

Crawford has said that he's looking for ways to help the FDA change "philosophies and work habits" that have stifled new innovation. He said at a Drug Information Association event last fall that the "sequencing of the human genome and the dramatic advances of genomics, proteomics, medical imaging and nanotechnology, combined with the user fee-supported acceleration of the FDA's product reviews, were expected to fill the R&D pipelines with scores of novel drugs and medical devices. That's not what happened ..."

The National Cancer Institute's Alliance for Nanotechnology in Cancer is pushing for improvement of this process through a number of "fast-track" mechanisms. Based on Crawford's past statements, it sounds like he's going to be very receptive to these new ideas. (Of course, he'll also need to deal with those who say what's needed is a slower track, based on recent bad calls by the FDA).

NanoBot Backgrounder
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