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The Outliers: Ammonia N13 and Voluven

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

In 2007, both CDER and CBER included in their final count of novel approvals products that had been cleared under the 505(b)(2) pathway - which is an expedited type of application that relies on sharing data with similar products that are on the market (and thus making products approved as 505(b)(2) by definition not unique).

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