Statement by Mary K. Pendergast, Deputy Commissioner, Senior Advisor to the Commissioner, Food and Drug Administration, Department of Health and Human Services

comprehensive program of on-site inspections and data audits.
FDA uses a combination of surveillance, enforcement, and
education to achieve regulatory compliance. Under the Agency's
Bioresearch Monitoring Program (BIMO), FDA field investigators
and headquarters' scientists conduct site visits of research
sponsors, clinical investigators, contract research
organizations, IRBs, radioactive drug research committees, and
non-clinical (animal) laboratories. In Fiscal Year 1996, FDA
conducted approximately 1,070 inspections under the program.2
The BIMO program is implemented through several compliance
programs: 1) Good Laboratory Practice (GLP) Program (Nonclinical Laboratory); 2) Clinical Investigator Program;
3) Institutional Review Board Program; 4) Sponsor, Contract
Research Organization, and Monitoring Program; 5) In Viv
Bioequivalence Program; and, 6) Radioactive Drug Research
Committee (RDRC) Program. The Clinical Investigator Program
and the IRB Program are the primary programs for ensuring
compliance with the informed consent requirements for human
subjects in clinical trials.
2Excludes color additives and radioactive drug research

committee inspections, and includes domestic and foreign
inspections.

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