Center for Biologies Evaluation and Research 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... 

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,... 

Center for Biologies Evaluation and Research. CBER s Report to the Biologies Community—2000, FDA, Rockvhle, MD, 2000. http //ww.fda.gov/cber/inside/biolrpt.htm [accessed March 7,2002]. 

Research (CDER) for small molecule synthetic drugs and therapeutic biologies, and the Center for Biologies Evaluation and Research (CBER) for non-therapeutic biologies (see Sections 7.2.1 and 7.2.2). A pre-IND meeting can be arranged with the FDA to discuss a number of issues ... 

In addition, during 2001 we interviewed approximately 64 individuals in DoD, FDA, the pharmaceutical industry, academia, and related organizations. A list of those interviewed can be found at the end of the report. Within FDA, we interviewed officials in the Center for Biologics Evaluation and Research (CBER), which has primary responsibility for vaccines and other biologics. We also interviewed officials in the Center for Drug Evaluation and Research (CDER), the larger of the two centers, which has responsibilities for pharmaceutical drugs. In the private sector, we interviewed individuals in both the pharmaceutical development industries and in the for-profit and not-for-profit pharmaceutical E T establishment. 

Center for Biologies Evaluation and Research. CBER Vision 2004. Strategic Plan for 2004. 

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