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Title
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Room
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* ! Statistical Issues in the Fast Track Approval Program for New Drug Applications
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H-Grand Ballroom B
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Date / Time
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Sponsor
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Type
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08/08/2001
10:30 AM
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12:20 PM
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Biopharmaceutical Section*, ENAR
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Invited
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Organizer:
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Weichung Shih, University of Medicine and Dentistry of New Jersey
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Chair:
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Aloka Chakravarty, FDA
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Discussant:
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Floor Discussion
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12:15 PM
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Description
The fast track programs of the FDA are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. There is a general 'Guidance for Industry' prepared by CDER and CBER, FDA, in 1998 following the FDA Modernization Act of 1997. This session will discuss statistical issues arising from the guidance. FDA statisticians will present their experiences and discuss issues encountered during review of NDAs for anti-cancer and anti-viral drugs. For example, an outstanding issue involves secondary (surrogate) endpoints during the fast track submission for accelerated approval, and also controlling the type-I error rate for the primary endpoint for the final approval as well as for the accelerated approval.
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