Influence of regulatory systems: A viewpoint of the US FDA process
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.
KeywordsSafety Evaluation Product Development Strategy Common Technical Document Conventional Pharmaceutical Preclinical Safety Evaluation
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- PhRMA (1996). 2996 Survey of Biotechnology Medicines in Development. Presented by the Pharmaceutical Research and Manufacturers of America.Google Scholar
- 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
- 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/access.gpo.gov/su_docs/ aces / acesl 40.html)Google Scholar
- 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