Abstract Details
Activity Number:
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62
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Type:
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Topic Contributed
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Date/Time:
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Sunday, August 9, 2015 : 4:00 PM to 5:50 PM
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Sponsor:
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Biopharmaceutical Section
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Abstract #317007
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View Presentation
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Title:
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Regulatory Challenges in Reviewing Targeted Therapy Trial
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Author(s):
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Kun He* and Rajeshwari Sridhara
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Companies:
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DBV/OB/CDER/FDA and FDA
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Keywords:
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targeted therapy
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Abstract:
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In recent years, there are more oncology trials that are planned to include molecularly defined small target patient population. Since such trials usually involve unique and specific features compared to traditional trials, we will discuss some examples and challenges in reviewing these trials from a regulatory perspective.
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Authors who are presenting talks have a * after their name.
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