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Activity Number: 62
Type: Topic Contributed
Date/Time: Sunday, August 9, 2015 : 4:00 PM to 5:50 PM
Sponsor: Biopharmaceutical Section
Abstract #317007 View Presentation
Title: Regulatory Challenges in Reviewing Targeted Therapy Trial
Author(s): Kun He* and Rajeshwari Sridhara
Companies: DBV/OB/CDER/FDA and FDA
Keywords: targeted therapy

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.

Authors who are presenting talks have a * after their name.

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