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FDA Often Looks Outside The Application, Review Documents Show

 
• By Mary Jo Laffler

A look back at the past year of Pharmaceutical Approvals Monthly’s Drug Review Profile series illustrates the many ways FDA takes external factors into consideration when reviewing an application – from guiding trials to look for certain class safety signals to finding support for a particular endpoint.

For better or for worse, FDA often looks outside the scope of a particular new drug application for guidance in its regulatory reviews. A look at Pharmaceutical Approvals Monthly’s 2013 series of Drug Review Profiles highlights some of the ways that external factors can affect pending applications.

Though the agency is bound to the dataset in front of it, reviewers take the broader context into account as...

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