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If the FDA is aiming to break records for producing guidances this year, it's off to a good start. Just this week, the agency released a spate of draft and final guidances touching on a range of drug and device issues.

As U.S. courts and states clear the way for drug and device companies to speak more about their products, "the FDA can't afford to sit still and silent," Peter Lurie, president of the Center for Science in the Public Interest, said Tuesday at a symposium on transparency at the agency.

In the five years since it started collecting generic drug user fees, the FDA has hired 1,000 new employees, amped up its staff training and completely reorganized the way it reviews abbreviated new drug applications (ANDAs).

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