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Center for Drugs Evaluation and Research CDER

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). [Pg.89]

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,... [Pg.525]

Center for Drug Evaluation and Research (CDER), 11 47 18 687 21 572 Freedom of Information Electronic Reading Room, 18 701-702 Center for Food Safety and Applied Nutrition (CFSAN), 21 572, 578 Center for Veterinary Medicine (CVM), 21 572, 579... [Pg.158]

See also Center for Drug Evaluation and Research (CDER) guidance page http //www. fda. gov/cder/guidance/index, htm. [Pg.774]

The guidelines on drug preparation (GLP and cGMP eompliance), regulatoiy issues are described in details in the Center for Drug Evaluation and Research (CDER) by the FDA [16], A complete seetion is dedieated to aetive pharmaceutical ingredient (API) and the GMP issues. The readers are encouraged to seek the reference for further details. [Pg.252]

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. [Pg.30]

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CDER

CDER (Center for Drug Evaluation and

Center for Drug Evaluation

Centers for

Drugs evaluation

Evaluation and Research

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