Drug Safety Evaluation Board

The Drug Safety Evaluation Board may allocate priority evaluation to applications for registration of important new medicines. The current criteria for priority evaluation are ... 

Board, National Academy of Sciences-National Research Council, Application of Metabolic Data to Drug Safety Evaluation, Clin. Pharmacol. Ther. (1969) 6 (5) 607-634. 

M David C Scales BSc PhD MSc LLM is Worldwide Director of Bioanalysis and Drug Metabolism for Glaxo Wellcome with responsibility for laboratories in the UK and the USA. He is Chairman of the Centre for Medicines Research International s Safety Evaluation Advisory Board and is the visiting Professor of Toxicology at the School of Pharmacy of the University of London. He is a Fellow of the Royal... 

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). 

CAAA CDC CDER CSB Clean Air Act Amendments Center for Disease Control and Prevention Center for Drug Evaluation and Research U.S. Chemical Safety and Hazard Investigation Board... 

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