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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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ASA, IMS, JQT Review Board, Health Informatics, ASA, ENAR, WNAR, IMS, SSC, Section on Bayesian Stat. Sciences*, Biometrics Section*, Biopharmaceutical Section*, Business & Economics Statistics Section*, Section on Statistical Computing*, Section on Statistical Consulting*, Section on Statistical Education*, Section on Statistics & the Environment*, Section on Statistics in Epidemiology*, Section on Government Statistics*, Section on Statistical Graphics*, Section on Health Policy Statistics*, Section on Statistics and Marketing, Section on Physical & Engineering Sciences*, Section on Quality & Productivity*, Section on Risk Analysis, Social Statistics Section*, Section on Statistics in Sports*, Section on Survey Research Methods*, Section on Teaching of Statistics in the Health Sciences*, General Methodology, Classification Society of North America, Intl Chinese Statistical Association, Intl Indian Statistical Association, Natl Inst of Statistical Sciences, Natl Science Foundation, Cmte on Gay and Lesbian Concerns in Statistics, Cmte on Minorities in Statistics, Cmte on Privacy and Confidentiality, JBES, Technometrics, Chance, The American Statistician, Council of Chapters, ASA Atlanta Chapter, Caucus for Women in Statistics, Cmte on Professional Ethics, Mu Sigma Rho, Korean Statisticians in America, Merck & Co, Indian Statistical Institute, Gay & Lesbian Statisticians' Caucus, University of North Carolina Alumni, Texas A&M University Alumni, SMU Alumni & Friends, Interface Foundation of North American Stat Assn, Communications in Statistics, Census Research Meeting, Isolated Biostatisticians, Association of GCRC Statisticians, John Wiley & Sons, Isolated Statisticians, Cmte on Women in Statistics, Council of Sections, Cmte on Meetings, Cmte on Committees, Individual Membership Subcmte, JASA Book Review, ASA/SIAM Book Series, Carnegie Mellon Alumni & Faculty, Advisory Cmte on Continuing Education, Cmte on Statistics & Disabilities, JABES, JCGS, CIS, Cmte of Representatives to AAAS, Cmte on Career Development, Council of Presidents of Stat Societies, ASA Finance Committee, ASA/MAA Joint Cmte on Undergrad Stats, Academic Program Representatives, Cmte on ASA Archives & Historical Materials, Cmte on Membership, National Institute of Statistical Societies (NISS), Section on Nonparametric Statistics, Natl Research Ctr for Stats in the Environment, JSE, Cmte on Scientific Freedom and Human Rights, Intl Society for Bayesian Analysis (ISBA), Cmte on Statisticians in Defense and National Security, American Educational Research Association (AERA), Memorial Sessions, Amstat Online, Capital One, Household Credit Services, RAND Statistics Group, Cancer Center Biostatistics Directors, Forest Service Statisticians, Addison Wesley, Christian Statisticians, Hispanic Statisticians, Insightful Corporation, University of Pittsburgh, University of Connecticut, Eli Lilly and Company, Advisory Cmte on Teacher Enhancement, Committee on Publications, Science & Public Affairs Advisory Committee, Deming Lectureship Committee, STATS Magazine, Committee on Outreach, SPAIG, Development Committee, Iowa State University Alumni, Noether Award Committee, W J Youden Award in Interlaboratory Testing Cmte, JSM 2002 Program Committee, JSM Advisory Committee, Organizational Membership Committee, Special Subcommittee on Meetings, Key College Publishing, North Carolina State University, Duxbury/Thomson Learning, International Chinese Statistical Association, Statistics in Medicine, Cmte on Applied and Theoretical Statistics, ENAR, IMS, Section on Bayesian Stat. Sciences*, Biometrics Section*, Business & Economics Statistics Section*, Section on Statistical Computing*, Section on Statistical Consulting*, Section on Statistical Education*, Section on Statistics & the Environment*, Section on Statistics in Epidemiology*, Section on Government Statistics*, Section on Statistical Graphics*, Section on Health Policy Statistics*, Section on Physical & Engineering Sciences*, Section on Quality & Productivity*, Social Statistics Section*, Section on Statistics in Sports*, Section on Survey Research Methods*, Section on Teaching of Statistics in the Health Sciences*, General Methodology, Intl Indian Statistical Association, Cmte on Minorities in Statistics, Cmte on Privacy and Confidentiality, JASA, Theory and Methods, JASA, Applications, Caucus for Women in Statistics, Cmte on Women in Statistics, Council of Sections, Section on Nonparametric Statistics, ASA Alaska Chapter, ENAR, WNAR, IMS, Section on Bayesian Stat. Sciences*, Biometrics Section*, Business & Economics Statistics Section*, Section on Statistical Consulting*, Section on Statistical Education*, Section on Government Statistics*, Section on Statistical Graphics*, Section on Health Policy Statistics*, Section on Quality & Productivity*, Social Statistics Section*, Section on Survey Research Methods*, Section on Teaching of Statistics in the Health Sciences*, JASA, Theory and Methods, Caucus for Women in Statistics, Association of GCRC Statisticians, Cmte on Meetings, Washington Statisticial Society, Noether Award Committee, ENAR, IMS, SSC, Section on Statistical Consulting*, Section on Government Statistics*, Section on Health Policy Statistics*, Social Statistics Section*, WNAR, SSC, Cmte on Minorities in Statistics, Section on Statistical Graphics*, Section on Physical & Engineering Sciences*, Section on Quality & Productivity*
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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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