FDA approves surging number of NDAs

The FDA approved 15 NDAs in October, the biggest month of the year for the agency. In the UPI story, analysts say that year-to-date approvals put this year in line with 2004, the best year for regulatory approvals in the Bush administration. Analysts are sounding worried, though, that a new Democratic majority will push through regulations that slow FDA actions. But where's the research and analysis on the number of new NDAs that are directed at the FDA? The regulators aren't acting in a vacuum. A rising tide of approvals has to be directly tied to an increase in the number of successful clinical trials. One analyst says that the new emphasis on safety at the FDA is likely to benefit companies that provide much of the work in the field, like clinical research organizations.

- read the UPI report on the NDA trend

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