Rep. Paulsen Drafting Legislation To Streamline FDA Reviews

Article preview from "The Gray Sheet"- June 6, 2011

Congressman Erik Paulsen says he is drafting legislation to "modernize and streamline" FDA, with an eye to restoring predictability and the balance between safety and innovation.

Rep. Paulsen Drafting Legislation To Streamline FDA Reviews

Article preview from "The Gray Sheet"- June 6, 2011

"FDA has a statutory mandate to consider the least burdensome means of demonstrating devices meet safety and efficacy standards. Unfortunately in recent years the agency has abandoned this principle," the Minnesota Republican said during a June 2 House Oversight Committee hearing on FDA's medical device approval program.

"The least burdensome provision should force the agency to find appropriate balance between patient protection and the development of new lifesaving products," Paulsen said. "I'm working on legislation to restore this balance at the agency and other efforts to modernize and streamline the FDA."

The congressman said he hopes to introduce a bipartisan bill in the next month and a half, before the August recess.

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