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SPONSORS, CONTRACT RESEARCH ORGANIZATIONS AND MONITORS
Date of Issuance: February 21, 2001
Guidance for FDA Staff
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This document is intended to provide guidance. It represents
the Agencys current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind Food and Drug Administration (FDA) or
the public. An alternative approach may be used if such approach satisfies the
requirements of the applicable statute and regulations. |
Hypertext updated April 5, 2001 tmc |