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Non-Hodgkin's lymphoma initial studies may use historical controls -- FDA advisory committee.

Executive Summary

NON-HODGKIN's LYMPHOMA AGENT INITIAL STUDIES: HISTORICAL CONTROLS ACCEPTABLE to determine whether response rates reflect meaningful clinical benefit over existing therapies, members of FDA's Biological Response Modifiers Advisory Committee agreed at an Oct. 21 meeting. The committee discussed clinical trial issues for drugs and biologics being developed for non-Hodgkin's lymphoma in the context of FDA's oncologics initiative.
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PS029087

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