Capturing the Full Power of Biomaterials for Military Medicine

by National Research Council, Division on Engineering and Physical Sciences, National Materials Advisory Board, Board on Manufacturing and Engineering Design, Committee on Capturing the Full Power of Biomaterials for Military Medical Needs

2004 · National Academies Press

Recent results in biomaterials R&D suggest that there are exceptional opportunities for these emerging materials in military medicine. To facilitate this possibility, the National Research Council convened a workshop at the request of the Department of Defense to help create a technology development roadmap to enhance military R&D into biomaterials technology. The workshop focused primarily on identifying useful near- and mid-term applications of biomaterials including wound care, tissue engineering, drug delivery, and physiological sensors and diagnostics. This report presents a summary of the workshop. It provides a review of biomaterials and their importance to military medicine, the roadmap, and a discussion of ways to enable biomaterials development. Several important outcomes of successful capture of potential benefits of these materials are also discussed.

A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration

by Institute of Medicine, National Research Council, Division on Earth and Life Studies, Board on Environmental Studies and Toxicology, Committee on Ranking FDA Product Categories Based on Health Consequences, Phase II

2011 · National Academies Press

With the responsibility to ensure the safety of food, drugs, and other products, the U.S. Food and Drug Administration (FDA) faces decisions that may have public-health consequences every day. Often the decisions must be made quickly and on the basis of incomplete information. FDA recognized that collecting and evaluating information on the risks posed by the regulated products in a systematic manner would aid in its decision-making process. Consequently, FDA and the Department of Health and Human Services (DHHS) asked the National Research Council (NRC) to develop a conceptual model that could evaluate products or product categories that FDA regulates and provide information on the potential health consequences associated with them. A Risk-Characterization Framework for Decision-Making at the Food and Drug Administration describes the proposed risk-characterization framework that can be used to evaluate, compare, and communicate the public-health consequences of decisions concerning a wide variety of products. The framework presented in this report is intended to complement other risk-based approaches that are in use and under development at FDA, not replace them. It provides a common language for describing potential public-health consequences of decisions, is designed to have wide applicability among all FDA centers, and draws extensively on the well-vetted risk literature to define the relevant health dimensions for decision-making at the FDA. The report illustrates the use of that framework with several case studies, and provides conclusions and recommendations.

Review of the Federal Strategy for Nanotechnology-Related Environmental, Health, and Safety Research

by National Research Council, Division on Engineering and Physical Sciences, National Materials Advisory Board, Division on Earth and Life Studies, Board on Environmental Studies and Toxicology, Committee for Review of the Federal Strategy to Address Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials

2009 · National Academies Press

This new book from the National Research Council finds serious weaknesses in the government's plan for research on the potential health and environmental risks posed by nanomaterials, which are increasingly being used in consumer goods and industry. An effective national plan for identifying and managing potential risks is essential to the successful development and public acceptance of nanotechnology-enabled products. The book recommends a robust national strategic plan for addressing nanotechnology-related EHS risks, which will need to focus on promoting research that can assist all stakeholders, including federal agencies, in planning, controlling, and optimizing the use of engineered nanomaterials while minimizing EHS effects of concern to society. Such a plan will ensure the timely development of engineered nanoscale materials that will bring about great improvements in the nation's health, its environmental quality, its economy, and its security.