Center for Drugs Evaluation and Research

Once the FDA receive the initial submission, an IND reference number is assigned. The application is then passed on to the appropriate review centre either the Center for Drug Evaluation and Research (CDER), or the Center for Biologies Evaluation and Research (CBER). Various experts will then review the submitted documents, the purpose being to ensure that the safety of subjects is not compromised and, in the case of Phase II and III studies, that the quality of study design is scientifically adequate. The FDA are allowed 30 days to complete the initial review, after which the study can commence, provided that it has been approved by an Institutional Review Board (IRB). 

U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologies Evaluation and Research (CBER). Guidance for Industry Population Pharmacokinetics. http //www.fda.gov/cder/guidance/1852fnl.pdf (accessed October 1,... 

US Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research. Center for Biologies Evaluation and Research. 

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG EVALUATION AND RESEARCH... 

Fig. 2 Organizational chart for the Center for Drug Evaluation and Research.

The general principles of bioequivalence as used by the FDA Center for Veterinary Medicine are essentially the same as those used by the Center for Drug Evaluation and Research when the products are designed for use by companion animals [44]. 

Source Data from which this chart was generated are from the Food and Drug Administration Center for Drug Evaluation and Research Web site (www.fda.gov/cder). 

Center for Drug Evaluation and Research (CEDR) Postmarketing Surveillance Programs, www.fda.gov/cder/regulatory/applications/postmarketing/ surveillancepost.htm (accessed May 24, 2002). 

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