Preparing for Future Products of Biotechnology
2017

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Between 1973 and 2016, the ways to manipulate DNA to endow new characteristics in an organism (that is, biotechnology) have advanced, enabling the development of products that were not previously possible. What will the likely future products of biotechnology be over the next 5–10 years? What scientific capabilities, tools, and/or expertise may be needed by the regulatory agencies to ensure they make efficient and sound evaluations of the likely future products of biotechnology?

Preparing for Future Products of Biotechnology analyzes the future landscape of biotechnology products and seeks to inform forthcoming policy making. This report identifies potential new risks and frameworks for risk assessment and areas in which the risks or lack of risks relating to the products of biotechnology are well understood.

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230 pages · 7 x 10 · paperback
ISBN Paperback: 0-309-45205-8
ISBN Ebook: 0-309-45206-6
DOI: https://doi.org/10.17226/24605

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National Academies of Sciences, Engineering, and Medicine. 2017. Preparing for Future Products of Biotechnology. Washington, DC: The National Academies Press.

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Front Matter i-xviii
Summary 1-14
1 Introduction and Context 15-26
2 Emerging Trends and Products of Biotechnology 27-66
3 The Current Biotechnology Regulatory System 67-106
4 Understanding Risks Related to Future Biotechnology Products 107-136
5 Opportunities to Enhance the Capabilities of the Biotechnology Regulatory System 137-170
6 Conclusions and Recommendations 171-186
Glossary 187-190
Appendix A: Biographical Sketches of Committee Members 191-196
Appendix B: Agendas of Information-Gathering Sessions 197-202
Appendix C: Requests for Information 203-208
Appendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates 209-212

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Preparing for Future Products of Biotechnology (2017)

Chapter: 1 Introduction and Context

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Publication information

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Preparing for Future Products of Biotechnology (2017)

Chapter: 1 Introduction and Context