FDA rolls out next-generation review system

01/6/2009 | RPM Report (free registration), The

The FDA is rolling out its "21st Century Review Process," which is expected to improve product review work-flow timelines and lead to more first-cycle product approvals. However, two parts of the FDA Amendments Act -- the Risk Evaluation and Mitigation Strategies and the advisory committee requirement for most novel products -- could make it difficult for the agency to meet its deadline goals, this RPM Report analysis says.

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RPM Report (free registration), The

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