ARTICLES BY JANICE HOGAN
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Optimizing FDA Submissions For Companion Diagnostics: Alternative Evaluation Pathways To Streamline Approval6/17/2016
In part one of this series, we examined the history of companion diagnostic approvals by FDA and identified trends to suggest better approaches to optimize the review process. Here, we will analyze new avenues sponsors may consider to further streamline the review of these important products through the assessment of various regulatory submission types and FDA guidance.
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Optimizing FDA Submissions For Companion Diagnostics6/13/2016
In this article — part one of a two-part series — we will examine the history of companion diagnostic approvals by FDA. Through this process, trends can be identified to suggest better approaches to optimize review times.
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