CBER responsibilities

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... 

Regulatory authority for gene therapy products is unique in that overlapping responsibilities extend to both CBER and NIH. 

In any case, injection site responses (erythemia, edema, pain, and tenderness) and systemic responses are both evaluated in subjects (Mathieu, 1997). USFDA also has specific guidance on the tracking and reporting of adverse clinical responses to vaccines. Any adverse events or product problems with vaccines should not be sent to MedWatch but to the Vaccine Adverse Event Reporting System (VAERA), operated jointly by FDA and the national Centers for Disease Control and Prevention. For a copy of the VAERS form, call 1-800-822-7967, or download the form (in PDF format) from www.fda.gov/cber/vaers/vaersl.pdf on FDA s Website. 

Under the revised system, CBER will continue to review blood products and vaccines. These product areas are CBER s strengths and the basis for creation of the biologies division. CBERwill also be responsible for evaluating gene therapy and tissue transplantation products as the development of these novel entities comes to fruition. 

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. 

FDA provided DoD officials customized E T in Fehmary 2000, which was considered useful hy many of those we interviewed in both DoD and FDA. CBER s Office of Commimication, Training and Manufacturers Assistance presented a basic course on FDA-CBER for both DoD and the Centers for Disease Control and Prevention in response to the problems associated with the anthrax vaccine. FDA officials indicated to RAND that it was both possible and desirable for FDA to provide E T programs responsive to DoD needs. The lack of a central point of contact in DoD to discuss needed and available E T was viewed as a limiting factor. ... 

This FDA IND review checklist has been designed in consultation with FDA reviewers, industry consultants, and regulatory professionals to serve as a summary tool indicating the evaluative criteria used by the Center for Drug Evaluation and Research (CDER) and the Center for Biologies Evaluation and Research (CBER) to critique and assess applications received. It can be used internally as a part of the Quality Assurance process, as a guideline for regulatory development of an application, and/or as a self-assessment tool to predict likely FDA response to an application. 

Once a Sponsor determines that their product fits one of the definitions of a combination product, the sponsor then must determine the lead Center within the FDA that will assume regulatory responsibility for the product. This determination is made by considering the primary mode of action (PMOA) [4] of the product. In simple terms, if the main function of the product is a device function, then it is likely that the Center for Devices and Radiological Health (CDRH) will have primary responsibility for the product. On the other hand, either the Center for Biologies Evaluation (CBER) or the Center for Drug Evaluation and Research (CDER) will be assigned primary review responsibility based on whether the PMOA of the product is dependent on... 

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