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Comparative Effectiveness Reaches Into Drug Reviews, FDA Documents Show

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

As the health care reform debate focuses on the appropriate role of comparative effectiveness research, a look at FDA’s review practices gives some insight into how the agency already takes the concept into account in its review decisions.

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AstraZeneca's Motavizumab May Be The Canary In The Follow-On Coal Mine

When a significant drug application hits a snag, it can sometimes feel like the whole industry stumbles. Such is the case with AstraZeneca PLC’s motavizumab, which protects against the effects of respiratory syncytial virus and recently failed to get a timely regulatory approval. This suggests the government agency’s standards may be changing on a range of issues, from comparative effectiveness to data integrity.

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