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This is the preliminary program for the 2007 Joint Statistical
Meetings in Salt Lake City, Utah.
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The views expressed here are those of the individual authors and not necessarily those of the ASA or its board, officers, or staff. Back to main JSM 2007 Program page |
= Applied Session,
= Theme Session,
= Presenter
408
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Wed, 8/1/07, 10:30 AM - 12:20 PM | CC-255 A |
| Interacting with the FDA in Medical Device Pre-market Applications: From Pre-IDE to PMA Submission - Topic Contributed - Papers | ||
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Biopharmaceutical Section, WNAR |
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| Organizer(s): Lilly Yue, Food and Drug Administration | ||
| Chair(s): Yao Huang, Food and Drug Administration | ||
| 10:35 AM |
Challenges in Trial Design for the Next Generation Drug-Eluting Stents —  Zheng Zhou, Boston Scientific Corporation; Peter Lam, Boston Scientific Corporation
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| 10:55 AM |
Pre-PMA Meetings with the FDA in Medical Device Submissions — Greg Campbell, Food and Drug Administration; Gerry Gray, Food and Drug Administration; Lilly Yue, Food and Drug Administration
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| 11:15 AM |
Some Thoughts on the Variables in Communications on Medical Device Studies Between the Sponsor and the FDA from the View of the Statistical Consultant — Dennis King, STATKING Consulting, Inc.
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| 11:35 AM |
One Statistician's Thoughts on Nonstatistical Issues That Affect Statistical Considerations in Medical Device Studies — Alicia Toledano, Biostatistics Consulting, LLC
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| 11:55 AM | Disc: Greg Campbell, Food and Drug Administration | |
| 12:15 PM | Floor Discussion | |
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JSM 2007
For information, contact jsm@amstat.org
or phone (888) 231-3473. If you have questions about the Continuing Education program,
please contact the Education Department. |