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Second Consecutive Year Of Growth In NME Approvals In The Cards For FDA

Executive Summary

It looks to be a good bet that 2009 will mark a second year of growth in new drug approvals: FDA entered the second half of the year with a robust first-half NME approval tally and a well-stocked pipeline of novel agents with user fee goal dates in the remaining months of the year

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FDA is using its new Risk Evaluation and Mitigation Strategy authorities much more frequently in the second year since the law took effect

The REMS Ramp Up: FDA Using New Safety Tools More Frequently In Year Two

FDA is using its new Risk Evaluation and Mitigation Strategy authorities much more frequently in the second year since the law took effect

Chart: Biologicals Approved In 2009

Biologicals Approved In 2009

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