Preparing for Future Products of Biotechnology

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. Table of ContentsFront MatterSummary1 Introduction and Context2 Emerging Trends and Products of Biotechnology3 The Current Biotechnology Regulatory System4 Understanding Risks Related to Future Biotechnology Products5 Opportunities to Enhance the Capabilities of the Biotechnology Regulatory System6 Conclusions and RecommendationsGlossaryAppendix A: Biographical Sketches of Committee MembersAppendix B: Agendas of Information-Gathering SessionsAppendix C: Requests for InformationAppendix D: Congressionally Defined Product Categories That the U.S. Food and Drug Administration Regulates