Mitochondrial replacement techniques (MRTs) are designed to prevent the transmission of mitochondrial DNA (mtDNA) diseases from mother to child. While MRTs, if effective, could satisfy a desire of women seeking to have a genetically related child without the risk of passing on mtDNA disease, the technique raises significant ethical and social issues. It would create offspring who have genetic material from two women, something never sanctioned in humans, and would create mitochondrial changes that could be heritable (in female offspring), and therefore passed on in perpetuity. The manipulation would be performed on eggs or embryos, would affect every cell of the resulting individual, and once carried out this genetic manipulation is not reversible. Mitochondrial Replacement Techniques considers the implications of manipulating mitochondrial content both in children born to women as a result of participating in these studies and in descendants of any female offspring. This study examines the ethical and social issues related to MRTs, outlines principles that would provide a framework and foundation for oversight of MRTs, and develops recommendations to inform the Food and Drug Administration's consideration of investigational new drug applications. Table of Contents Front Matter Summary 1 Introduction 2 Science and Policy Context 3 Do Ethical, Social, and Policy Considerations Preclude MRT? 4 Regulation and Oversight of MRT in Humans Appendix A: Study Approach Appendix B: Summary of MRT Research Appendix C: Biosketches of Committee Members

Tuberculosis (TB) kills approximately 4,500 people worldwide every day. While most cases of TB can be treated with antibiotics, some strains have developed drug resistance that makes their treatment more expensive, more toxic and less effective for the patient. The IOM Forum on Drug Discovery, Development, and Translation and the Academy of Science of South Africa held a workshop to discuss ways to fight the growing threat of drug-resistant TB. Table of Contents Front Matter 1 Introduction 2 The Incidence of Drug-Resistant TB in Southern Africa 3 Surveillance and Tracking of Drug-Resistant TB 4 Transmission and Infection Control 5 Diagnosis of Drug-Resistant TB 6 Treatment of Drug-Resistant TB 7 Drug-Resistant TB in Children 8 Convergence of Science and Policy to Create a Blueprint for Action References Appendix A: Agenda Appendix B: Report from the National Institute of Allergy and Infectious Diseases (NIAID) Workshop Appendix C: Participant Biographies

The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.