Table of Contents:
  • Introduction and context
  • Emerging trends and products of biotechnology
  • The current biotechnology regulatory system
  • Understanding risks related to future biotechnology products
  • Opportunities to enhance the capabilities of the biotechnology regulatory system
  • Conclusions and recommendations
  • Glossary
  • Appendix A: Biographical sketches of committee members
  • Appendix B: Agendas of information-gathering sessions
  • Appendix C: Requests for information
  • Appendix D: Congressionally defined product categories that the U.S. Food and Drug Administration regulates.