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Activity Number:
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14
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 6, 2006 : 2:00 PM to 3:50 PM
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Sponsor:
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Biopharmaceutical Section
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| Abstract - #306917 |
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Title:
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Statistical Review Quality Assessment for Therapeutic PMA Submissions
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Author(s):
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Lilly Yue*+
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Companies:
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U.S. Food and Drug Administration
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Address:
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1350 Piccard Drive, Rockville, MD, 20850,
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Keywords:
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therapeutic medical device ; planning clinical study ; preparing PMA submission
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Abstract:
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To standardize the structure of statistical review memos and ensure review quality, the Division of Biostatistics (DBS) in FDA's Center for Devices and Radiological Health developed a comprehensive list of items to be visited in an in-depth review of a PMA (premarket approval) application for a therapeutic device. This has served as a valuable source for statisticians in DBS when reviewing PMA submissions for therapeutic devices. In this presentation, I will emphasize elements of the list for a quality statistical review with the hope that such a regulatory perspective is useful to statisticians involved in planning clinical studies and preparing PMA submissions for therapeutic devices.
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