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Washington Roundup

PDUFA V Strives to Balance Safety with Timely Approvals

By Mari Serebrov

Monday, July 11, 2011
WASHINGTON – Amid criticism that the FDA has yet to strike the right balance between risk and benefit, the agency's Janet Woodcock gave a House subcommittee a sneak peak of proposed PDUFA V enhancements that would address those concerns.

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