Regulatory Reflections concerning the State of Biotechnology Progress *

Abstract

The premise of this paper is a concern over the dismal record of approvals for biotechnology products despite the enormous resources poured into their development. The authors have described a number of issues which may help to explain the dearth of biotechnology product approvals. Included among those issues are suggestions for improving the development process by ensuring the presence of several key resources which may be overlooked by emerging biotechnology companies. Particularly, the authors advocate creative approaches to development rather than relying too strongly on approaches used in the past. As well, the authors suggest that applicants should intelligently use the resources of the Food and Drug Administration (FDA) for guidance and input into the development process. Finally, the authors suggest that when both applicants and FDA work smarter and faster, there will be many more approvals of biotechnology products.