Tabla de Contenidos: “…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…”

Tabla de Contenidos: “…Opioid Approval And Monitoring By The U.S. Food And Drug Administration; Overview of the FDA's Regulatory Process for Prescription Drugs and Its Application to Opioids -- Public Health Dimensions of FDA Drug Regulation -- Key Elements of an Integrated Decision-Making Framework for Opioid Regulation -- Implementation of an Integrated Framework for Opioid Regulation -- Summary and Recommendations -- References -- Annex Table : Extended-Release(ER)/Long-Acting (LA) Opioid Post-Marketing Study Requirements…”

“…This report assesses the current global health landscape and how challenges, actions, and players have evolved over the last decade across a wide range of issues, and provides recommendations on how to increase responsiveness, coordination, and efficiency - both within the U.S. government and across the global health field…”

Tabla de Contenidos: “…""IDR Team Summary 3: Reconstructing gene circuitry: How can synthetic biology lead us to an understanding of the principles underlying natural genetic circuits and to the discovery of new biology?""""…”