CDER

Table 2.1 Biological products regulated by the CDER and CBER.

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). 

Figure 6.17 The NDA review process (from the CDER Handbook).

FDA. Guidance for Industry. PAT—A Framework for Innovative Pharmaceutical Development, Mannfactnring, and Qnality Assurance, http //www.fda.gov/cder/ guidence/6419fnl.htm... 

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,... 

Molecular Entities Approved 1995-1999. June 2001. Office of Special Health Issues, Office of International and Constituent Relations, Office of the Commissioner, U.S. Food and Drug Administration, http //www.fda.gov/cder/reports/ womens health/women clin trials.htm [accessed October 2005]. 

Drug Studies in Pediatric Patients Medical Officer s Review Statistical Review Evaluation Chemistry, Manufacturing and Controls CDER Labeling and Nomenclature Committee Clinical Pharmacology/Biopharmaceutics Microbiologist s Review Pharmacokinetics Review Carcinogenicity Assessment... 

The New Drug Development Process Steps from Test Tube to New Drug Application Review, [Internet]. URL http //www.fda.gov/cder/handbook/ develop, htm, accessed 7-29-2000. 

Manual of Policies and Procedures (MaPP6010.2). Review management. Procedures for tracking and reviewing phase 4 commitments, URL http //www.fda.-gov/cder/mapp/6010-2.pdf, accessed 3-10-2001. 

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). 

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