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FDA New Policies Regarding Transparency

Thu, 08/21/2008 - 11:11
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(FDA: Rockville, Maryland) -- The Food and Drug Administration (FDA) plans to implement several improved policies and procedures strengthening its management advisory committees. The improvements include stricter limits on financial conflicts of interest for committee members, improved voting procedures, and improvements to the processes for disclosing information pertaining both to advisory committee members and to specific matters considered at advisory committee meetings.

“The FDA’s regulatory decisions affect the health of millions of Americans, and we don’t make those decisions in a vacuum,” says Randall Lutter, Ph.D., deputy commissioner for policy. “It’s imperative that we seek advice from independent experts, and that we do so in a way that is public, open, and transparent.”

The policies and procedures are described in four final guidance documents, and proposed changes in policies are described in a draft guidance. Most of the changes in the final guidance documents will go into effect immediately, and all are expected to be fully implemented within 120 days.

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