During an interactive workshop on the evolving FDA, Catalyst President Nancy Bradish Myers explored some of the challenges faced by drug and device companies in getting new, cutting edge technologies through the FDA most appropriately and efficiently.
Leaders at the agency “really are trying to deal with this innovation concept, and trying not to be a hurdle,” Ms. Myers said. “The challenge I see for the agency is even though the people in leadership positions believe that, it’s not always trickling down to the reviewer level.”
“That’s where they’ve got to figure out how to take those great ideas, and make sure the guy looking at your application” is able to say “I can take a risk here,” she said.
She also explored FDA initiatives related to combination products, personalized medicine, regulatory science and small business programs.
The discussion took place at the Biotech Showcase 2012 meeting during the JP Morgan annual healthcare Conference in San Francisco.
To watch the panel video, click here.

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