FIGURE 5.1. Form FDA 483 Deficiencies Issued by CDER Since 1990.

FIGURE 5.1Form FDA 483 Deficiencies Issued by CDER Since 1990

NOTE: This table is based upon data from 483s issued in connection with FDA audits of human investigational drug studies. The analysis for the table was conducted by Center for Clinical Research Practice utilizing a listing of 483s issued over a span of 10 years (ending in January, 2002) by Center for Drug Evaluation and Research (CDER) and compiled by CDER (available at http://www.fda.gov/cder/regulatory/investigators/default.htm). The information does not include data from the Center for Devices and Radiological Health or the Center for Biologics Evaluation and Research.

From: 5, Improving Protection Through Oversight and Data and Safety Monitoring

Cover of Responsible Research
Responsible Research: A Systems Approach to Protecting Research Participants.
Institute of Medicine (US) Committee on Assessing the System for Protecting Human Research Participants; Federman DD, Hanna KE, Rodriguez LL, editors.
Washington (DC): National Academies Press (US); 2002.
Copyright © 2003, National Academy of Sciences.

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