Abstract #302055

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JSM 2002 Abstract #302055
Activity Number: 126
Type: Luncheons
Date/Time: Monday, August 12, 2002 : 12:30 PM to 1:50 PM
Sponsor: Biopharmaceutical Section*
Abstract - #302055
Title: FDA Guidance on Clinical Trial Data Monitoring Committees
Author(s): Susan Ellenberg*+
Affiliation(s): Food and Drug Administration
Address: 1401 Rockville Pike, HFM-210, Rockville, MD, 20852,
Keywords:
Abstract:

The Food & Drug Administration (FDA) has issued a draft guidance document on the establishment and operation of clinical trial data monitoring committees in the fall of 2001. This document provides the first detailed regulatory commentary on the use of data monitoring committees in trials of FDA-regulated products. This roundtable will address the major points of this new document and will provide the opportunity to clarify and discuss the various issues raised in the document.

  • The address information is for the authors that have a + after their name.
  • Authors who are presenting talks have a * after their name.

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JSM 2002

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Revised March 2002