Influence of regulatory systems: A viewpoint of the US FDA process

  • Joy A. Cavagnaro
Part of the CMR International Workshop Series book series (CMRW)


1. The Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration (FDA) is responsible for the regulation of over 85% of the biotechnology-derived medicines/vaccines currently in development in the USA.


Safety Evaluation Product Development Strategy Common Technical Document Conventional Pharmaceutical Preclinical Safety Evaluation 
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  1. PhRMA (1996). 2996 Survey of Biotechnology Medicines in Development. Presented by the Pharmaceutical Research and Manufacturers of America.Google Scholar
  2. Cavagnaro J (1996). Safety testing of biotechnology products: Rapporteur’s report. In D’Arcy PF and Harron DWG (eds.) Proceedings of the Third International Conference on Harmonisation, Yokohama 1995. The Queens University of Belfast, Belfast, pp. 226–230.Google Scholar
  3. Federal Register (1995-97). Elimination of establishment license application for specified biotechnology and specified synthetic biological products. (May 14, 1996-61 FR 24227); Guidance for industry for the submission of chemistry, manufacturing, and controls information for a therapeutic recombinant DNA-derived product or a monoclonal antibody product for in vivo use (October 31,1996–61 FR 56243); FDA guidance document concerning use of pilot manufacturing facilities for the development and manufacture of biological products ( July 11, 1995 — 60 FR 35750); and Revised form 356h application to market a new drug, biologic, or an antibiotic drug for human use ( July 8,1997-62 FR 36558). (Available at Internet address http://www/ aces / acesl 40.html)Google Scholar
  4. ICH (1997). ICH S6 document was finalised at ICH 4 in Brussels (July, 1997) International Conference on Harmonisation; Guidance on Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals (November 18, 1997-62 FR 61515). (The document issued by IFPMA in July 1997 is reproduced in full in Appendix I to this volume)Google Scholar

Copyright information

© Springer Science+Business Media Dordrecht 1998

Authors and Affiliations

  • Joy A. Cavagnaro

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