CDER's Role in FDA's Monitoring and Subject Safety

Several companies recently requested clarity pertaining to CDER's role in FDA's Bioresearch Monitoring Program and Human Subject Protection. The Center for Drug Evaluation and Research (CDER) consists of the following offices and divisions:

• Office of the Center Director
• Office of Compliance
• Division of Scientific Investigations (DSI)
• Division of Manufacturing and Product Quality
• Division of Compliance Risk Management and Surveillance
• Division of New Drugs and Labeling Compliance.

The Division of Scientific Investigations (DSI) consists of a Director, Deputy Director, Field Investigator, Good Clinical Practice (GCP) Branch 1, GCP Branch 2 and Good Laboratory Practice (GLP)/Bioequivalence and Quality (BEQ).

CDER's Bioresearch Monitoring (BIMO) Inspection Programs consist of :

• Clinical Investigators
• Sponsor/Monitor/CRO Investigators
• IRB/RDRC Investigators
• Bioequivalence/Good Laboratory Practice Investigators.

The goals of BIMO:

• validity of data from studies in support of pending marketing applications
• adherence to FDA GCP/GLP/BEQ regulations
• whether the rights and safety of subjects have been protected.

More to come on CDER's role and organization...