The Institute of Medicine's (IOM's) Roundtable on Research and Development of Drugs, Biologics, and Medical Devices evolved from the Forum on Drug Development, which was established in 1986. Sponsor representatives and IOM determined the importance of maintaining a neutral setting for discussions regarding long-term and politically sensitive issues justified the need to revise and enhance past efforts. The new Roundtable is intended to be a mechanism by which a broad group of experts from the public* and private sectors can be convened to conduct a dialogue and exchange information related to the development of drugs, biologics, and medical devices. Members have expertise in clinical medicine, pediatrics, clinical pharmacology, health policy, health insurance, industrial management, and product development; and they represent interests that address all facets of public policy issues. From time to time, the Roundtable requests that a workshop be conducted for the purpose of exploring a specific topic in detail and obtaining the views of additional experts. The first workshop for the Roundtable was held on April 14 and 15, 1998, and was entitled Assuring Data Quality and Validity in Clinical Trials for Regulatory Decision Making. The summary on that workshop is available from IOM. This workshop summary covers the second workshop, which was held on May 24 and 25, 1999, and which was aimed at facilitating the development and proper use of drugs, biologics, and medical devices for infants and children. It explores the scientific underpinnings and clinical needs, as well as the regulatory, legal, and ethical issues, raised by this area of research and development.

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) were designed to encourage more pediatric studies of drugs used for children. The FDA asked the IOM to review aspects of pediatric studies and changes in product labeling that resulted from BPCA and PREA and their predecessor policies, as well as assess the incentives for pediatric studies of biologics and the extent to which biologics have been studied in children. The IOM committee concludes that these policies have helped provide clinicians who care for children with better information about the efficacy, safety, and appropriate prescribing of drugs. The IOM suggests that more can be done to increase knowledge about drugs used by children and thereby improve the clinical care, health, and well-being of the nation's children.

THE ESSENTIAL WORK IN TRAVEL MEDICINE -- NOW COMPLETELY UPDATED FOR 2018 As unprecedented numbers of travelers cross international borders each day, the need for up-to-date, practical information about the health challenges posed by travel has never been greater. For both international travelers and the health professionals who care for them, the CDC Yellow Book 2018: Health Information for International Travel is the definitive guide to staying safe and healthy anywhere in the world. The fully revised and updated 2018 edition codifies the U.S. government's most current health guidelines and information for international travelers, including pretravel vaccine recommendations, destination-specific health advice, and easy-to-reference maps, tables, and charts. The 2018 Yellow Book also addresses the needs of specific types of travelers, with dedicated sections on: · Precautions for pregnant travelers, immunocompromised travelers, and travelers with disabilities · Special considerations for newly arrived adoptees, immigrants, and refugees · Practical tips for last-minute or resource-limited travelers · Advice for air crews, humanitarian workers, missionaries, and others who provide care and support overseas Authored by a team of the world's most esteemed travel medicine experts, the Yellow Book is an essential resource for travelers -- and the clinicians overseeing their care -- at home and abroad.

The Pocket Book is for use by doctors nurses and other health workers who are responsible for the care of young children at the first level referral hospitals. This second edition is based on evidence from several WHO updated and published clinical guidelines. It is for use in both inpatient and outpatient care in small hospitals with basic laboratory facilities and essential medicines. In some settings these guidelines can be used in any facilities where sick children are admitted for inpatient care. The Pocket Book is one of a series of documents and tools that support the Integrated Managem.

The evaluation of reproductive, maternal, newborn, and child health (RMNCH) by the Disease Control Priorities, Third Edition (DCP3) focuses on maternal conditions, childhood illness, and malnutrition. Specifically, the chapters address acute illness and undernutrition in children, principally under age 5. It also covers maternal mortality, morbidity, stillbirth, and influences to pregnancy and pre-pregnancy. Volume 3 focuses on developments since the publication of DCP2 and will also include the transition to older childhood, in particular, the overlap and commonality with the child development volume. The DCP3 evaluation of these conditions produced three key findings: 1. There is significant difficulty in measuring the burden of key conditions such as unintended pregnancy, unsafe abortion, nonsexually transmitted infections, infertility, and violence against women. 2. Investments in the continuum of care can have significant returns for improved and equitable access, health, poverty, and health systems. 3. There is a large difference in how RMNCH conditions affect different income groups; investments in RMNCH can lessen the disparity in terms of both health and financial risk.