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Washington Roundup

FDA: 505(q) Petitions Simply Way to Delay Competition

By Mari Serebrov
Washington Editor

Thursday, September 26, 2013
Prioritizing 505(q) petitions asking the FDA to take or stay action in pending approvals of biosimilars, generics and 505(b)(2) drugs is delaying action on more important matters, the agency told Congress in a recently submitted annual report.

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