CBER

Center for Biologies Evaluation and Research (CBER). This center is responsible for the regulation and approval of ah biological products intended for use in the treatment, prevention, or cure of diseases or injuries to humans. A biological product is any vims, therapeutic semm, toxin, antitoxin, vaccine, blood or blood component or derivative, or analogous product (5). It also includes products produced by biotechnology, such as interferons and erythropoietins. 

The Center for Biologies Evaluation and Research (CBER) is responsible for the oversight of what might be considered more traditional biological products, such as... 

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). 

FDA-2830 Blood Estabhshment Registration and Product Listing CBER... 

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,... 

Soruce Physicans Desk Reference, 52, 1998 www.fda.gov/cber/efoi/approve.htm. 

Biologies licenses issued by CBER include approval of a specific series of production steps and in-process... 

The criteria used by the CBER and CDER regulators in assessing product performance during the drug development process are similar, i.e. safety, quality and efficacy. However, the administrative details can vary in both name and content. Upon concluding preclinical trials, all... 

Table 4.8 Major biotechnology/biological-based drug types regulated by CDER and CBER ...

The dossier submitted to the CDER is known as a new drug application (NDA), which, if approved, allows the drug to be marketed. If the drug is a CBER-regulated one, then a biologies licence application (BLA) is submitted. 

Table 4.9 The major itemized points that must be included/ addressed in an IND application to CDER or CBER...

Food and Drug Administration (FDA) (2002) Report to Congress on Post-Marketing Surveillance of Drugs, March 13, 2002, available at www.fda.gov/cber/fdama/pstmrktfdamal30.htm (accessed May 30, 2002.)... 

CeUular Therapies. Since 1984 CBER has reviewed close to 300 somatic cell therapy protocols. Examples of the specific categories include manipulation, selection, mobilization, tumor vaccines and other. 

Anon. (1997h). Points to Consider in the Manufacture and Testing of Monoclonal Antibody Products for Human Use. http //www.fda.gov/cber/cberftp.html... 

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