Evaluation and Research

Dmg products must meet the requirements estabUshed by the Center for Dmg Evaluation and Research at FDA. They must comply with the appropriate OTC Dmg Review Fiaal Rule pubHshed ia the Federal Register or must be the subject of an approved New Dmg AppHcation (NDA) filed with FDA. Products not meeting these requirements are considered by FDA to be New Dmgs without an NDA and subject to regulatory action. 

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. 

Standardization and Testing". The Center for Biologies Evaluation and Research has set guidelines for the vaccine which include standards for si2e of the individual polysaccharides and specifications for both purity (absence of protein and nucleic acid) and chemical and immunological identity. 

Guidelinesfor Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances, Office of Drug Evaluation and Research (HFD-100), FDA, RockviUe, Md., 1987, pp. 3, 4. 

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,... 

Knapp s group have collaborated with the Centre for Human Sciences of the Defence Evaluation and Research Agency to evaluate the health economic considerations of PTSD (McCrone et al, in press). They have found that many factors need to be taken into account such as the prevention of PTSD, the discharge from the armed forces for military-related PTSD, and various treatment options. As yet, there are no clear estimates of the costs of treatment. 

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). 

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