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The Acquisition Of Drugs And Biologics For Chemical And Biological Warfare Defense Department Of Defense Interactions With The Food And Drug Administration
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Book Synopsis The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense. Department of Defense Interactions with the Food and Drug Administration by :
Download or read book The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense. Department of Defense Interactions with the Food and Drug Administration written by and published by . This book was released on 2003 with total page 94 pages. Available in PDF, EPUB and Kindle. Book excerpt: Chemical and biological threats confront U.S. military personnel today both overseas and in the continental United States, whether in defensive, peacekeeping, or offensive situations. Defenses against such threats are both medical and nonmedical. Drugs and biologics, mainly vaccines, constitute the primary medical defenses. Consequently, efforts of the U.S. Department of Defense (DoD) to protect American troops require the acquisition of drugs and biologics for chemical and biological warfare (CBW) defense. The objective of this acquisition, as is the case for other acquisitions, is to obtain the desired supply of a given product at an acceptable price. This study includes both drugs and biologics, but it emphasizes the latter (mainly focusing on vaccines, a subset of biologics). Vaccines provide advanced protection against biological warfare threats via immunization of at-risk troops and prior protection is a high priority within DoD. In contrast, drugs are useful mainly in treating already-exposed troops. Vaccine development is also more complicated than drug development because it typically involves manipulating live organisms, whereas drugs consist of more-stable chemical entities. DoD has two distinct roles during the acquisition of drugs and biologics for CBW defense: purchaser and developer. As purchaser of a drug approved by the U.S. Food and Drug Administration (FDA) for which a commercial market exists, DoD simply buys what it needs at the market price; DoD acquisition of influenza vaccine is a good example of this.
Book Synopsis The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense by : Richard A. Rettig
Download or read book The Acquisition of Drugs and Biologics for Chemical and Biological Warfare Defense written by Richard A. Rettig and published by Rand Corporation. This book was released on 2003 with total page 77 pages. Available in PDF, EPUB and Kindle. Book excerpt: The 1990-1991 Gulf War made clear the U.S. Department of Defense's (DoD's) need to effectively acquire drugs and biologics, mainly vaccines, as American troops faced the real threat of chemical and biological warfare (CBW) agents being used in combat. More than a decade after the war, DoD still experiences acute obstacles in obtaining CBW defense supplies. In response, the authors look at the department's relationship with the U.S. Food and Drug Administration (FDA) and suggest ways to improve it through such means as centralizing the department's acquisition authority and further educating DoD personnel.
Book Synopsis Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense by : Richard A. Rettig
Download or read book Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense written by Richard A. Rettig and published by Minnesota Historical Society. This book was released on 1999 with total page 128 pages. Available in PDF, EPUB and Kindle. Book excerpt: The confrontation that began when Iraq invaded Kuwait in August 1990 brought with it the threat that chemical and biological weapons might be used against the more than half a million military personnel the United States deployed to the region. To protect these troops from such threats, the Department of Defense wished to use drugs and vaccines that, not having been tested for use in these specific situations, were considered "investigational" by the federal Food and Drug Administration. This report examines the history of the Interim Rule, adopted in December 21, 1990, that authorized the Commissioner of Food and Drugs to waive informed consent for the use of investigational drugs and vaccines for certain military uses; how this authority was used for pyridostigmine bromide and botulinum toxoid during the Gulf War; and the subsequent controversy surrounding the rule, its application, and its implications. The report then analyzes the issues the Interim Rule raised when investigational drugs are used for such purposes and makes recommendations for dealing with similar situations in the future.
Book Synopsis Medical Aspects of Biological Warfare, 2e by : Joel Bozue
Download or read book Medical Aspects of Biological Warfare, 2e written by Joel Bozue and published by Government Printing Office. This book was released on 2018-08-01 with total page 1099 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reflecting the critical threat posed by biological warfare and terrorism in a post 9-11 world, Medical Aspects of Biological Warfare, 2e, addresses the weaponization of biological agents, categorizing potential agents as food, waterborne, or agricultural agents or toxins, and discusses their respective epidemiology. Recent advances in biomedical knowledge are presented that include descriptions of individual agents and the illnesses induced. Authors discuss biotoxins and explain methods for early identification for anthrax, plague, smallpox, alphaviruses, and staphylococcal enterotoxins. Case studies and research on successful management practices, treatments, and antidotes are also included. Contains updated and revised material since previous, 2007 edition.(Previous Print Hardcover ISBN: 9780160797316; eBook: 9780160872389) Related products: More published products by The Borden Institute, U.S. Army Medical Department (AMEDD) are here: https://bookstore.gpo.gov/agency/army-medical-department-amedd Arms & Weapons collection is available here: https://bookstore.gpo.gov/catalog/arms-weapons Click here to find resources about Hazardous Materials (HAZMAT & CBRNE). Find more Physician References and Medical Handbooks here: https://bookstore.gpo.gov/catalog/physician-references-medical-handbooks
Author :United States. Congress. House. Committee on Government Reform. Subcommittee on National Security, Veterans Affairs, and International Relations Publisher : ISBN 13 : Total Pages :68 pages Book Rating :4.F/5 ( download)
Book Synopsis Chemical and biological defense by : United States. Congress. House. Committee on Government Reform. Subcommittee on National Security, Veterans Affairs, and International Relations
Download or read book Chemical and biological defense written by United States. Congress. House. Committee on Government Reform. Subcommittee on National Security, Veterans Affairs, and International Relations and published by . This book was released on 2002 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Government Reform. Subcommittee on National Security, Veterans Affairs, and International Relations Publisher : ISBN 13 : Total Pages :70 pages Book Rating :4.:/5 (327 download)
Book Synopsis DOD Chemical and Biological Defense Program by : United States. Congress. House. Committee on Government Reform. Subcommittee on National Security, Veterans Affairs, and International Relations
Download or read book DOD Chemical and Biological Defense Program written by United States. Congress. House. Committee on Government Reform. Subcommittee on National Security, Veterans Affairs, and International Relations and published by . This book was released on 2001 with total page 70 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Food and Drug Administration Confronts Homeland and National Security by : Richard A. Rettig
Download or read book The Food and Drug Administration Confronts Homeland and National Security written by Richard A. Rettig and published by . This book was released on 2003 with total page 14 pages. Available in PDF, EPUB and Kindle. Book excerpt: Reviews a RAND workshop (Dec. 2002) on challenges faced by the U.S. Food and Drug Administration in the agency's potential response to increased national and homeland security needs for drugs and vaccines.
Book Synopsis Giving Full Measure to Countermeasures by : National Research Council
Download or read book Giving Full Measure to Countermeasures written by National Research Council and published by National Academies Press. This book was released on 2004-05-06 with total page 161 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, substantial efforts have been initiated to develop new drugs, vaccines, and other medical interventions against biological agents that could be used in bioterrorist attacks against civilian populations. According to a new congressionally mandated report from the Institute of Medicine and National Research Council of the National Academies, to successfully develop these drugs, vaccines, and other medical interventions against biowarfare agents, Congress should authorize the creation of a new agency within the Office of the Secretary of the U.S. Department of Defense. The committee recommended that Congress should improve liability protections for those who develop and manufacture these products, to stimulate willingness to invest in new research and development for biowarfare protection. Giving Full Measure to Countermeasures also identifies other challengesâ€"such as the need for appropriate animal models and laboratories equipped with high-level biosafety protectionsâ€"that will require attention if DoD efforts to develop new medical countermeasures are to be successful.
Download or read book 101 סיפורים ראשונים לילד written by and published by . This book was released on 1993 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :United States. Congress. House. Committee on Armed Services. Subcommittee on Military Procurement Publisher : ISBN 13 : Total Pages :108 pages Book Rating :4.0/5 (6 download)
Book Synopsis Chemical and Biological Defense for U.S. Forces by : United States. Congress. House. Committee on Armed Services. Subcommittee on Military Procurement
Download or read book Chemical and Biological Defense for U.S. Forces written by United States. Congress. House. Committee on Armed Services. Subcommittee on Military Procurement and published by . This book was released on 2000 with total page 108 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis From Lambs to Lions by : Thomas Preston
Download or read book From Lambs to Lions written by Thomas Preston and published by Rowman & Littlefield. This book was released on 2009-02 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: While many books discuss how nations can prevent the proliferation of biological and nuclear weapons, this unique and controversial volume begins with the premise that these weapons will certainly multiply despite our desperate desire to slow this process. How worried should we be and what should we do? Thomas Preston examines current trends in the proliferation of nuclear and biological weapons capabilities, know-how, and technologies for both state and nonstate actors and then projects these trends over the coming ten to fifteen years to assess how they might impact existing security relationships between states. Providing thorough discussion and analysis of a potentially nuclear North Korea and Iran, the current biotechnical revolution, and the future threat of attacks against the United States by terrorist organizations like Al Qaeda, Preston offers answers and some potentially surprising reassurances in this accessibly written and informative book. Book jacket.
Author :National Academies of Sciences, Engineering, and Medicine Publisher :National Academies Press ISBN 13 :0309672104 Total Pages :427 pages Book Rating :4.3/5 (96 download)
Book Synopsis Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis by : National Academies of Sciences, Engineering, and Medicine
Download or read book Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-04-24 with total page 427 pages. Available in PDF, EPUB and Kindle. Book excerpt: Among the many who serve in the United States Armed Forces and who are deployed to distant locations around the world, myriad health threats are encountered. In addition to those associated with the disruption of their home life and potential for combat, they may face distinctive disease threats that are specific to the locations to which they are deployed. U.S. forces have been deployed many times over the years to areas in which malaria is endemic, including in parts of Afghanistan and Iraq. Department of Defense (DoD) policy requires that antimalarial drugs be issued and regimens adhered to for deployments to malaria-endemic areas. Policies directing which should be used as first and as second-line agents have evolved over time based on new data regarding adverse events or precautions for specific underlying health conditions, areas of deployment, and other operational factors At the request of the Veterans Administration, Assessment of Long-Term Health Effects of Antimalarial Drugs When Used for Prophylaxis assesses the scientific evidence regarding the potential for long-term health effects resulting from the use of antimalarial drugs that were approved by FDA or used by U.S. service members for malaria prophylaxis, with a focus on mefloquine, tafenoquine, and other antimalarial drugs that have been used by DoD in the past 25 years. This report offers conclusions based on available evidence regarding associations of persistent or latent adverse events.
Book Synopsis Chemical and Biological Defense by : United States. General Accounting Office
Download or read book Chemical and Biological Defense written by United States. General Accounting Office and published by . This book was released on 2001 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Biodefense Research Supporting the DoD by : Coleen K. Martinez
Download or read book Biodefense Research Supporting the DoD written by Coleen K. Martinez and published by . This book was released on 2007-01-31 with total page 44 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Department of Defense (DoD) has had a unique mission in biological defense research over the past 4 decades. Throughout this history, the military biological disease threats were relatively straightforward, there was little urgency linked to successful product fielding, there was no mechanism by which to gain Food and Drug Administration (FDA) product licensure, and there was little competition for mission or funds. In the post-September 11, 2001 (9/11) environment, however, the scope of potential threats has increased immeasurably, relative funding for the DoD has decreased, urgency to field solutions has skyrocketed, the FDA has provided a way forward to product licensure, and active non-DoD players in this arena have grown exponentially, aligning with newly designated, congressionally mandated funding sources. The old paradigms that governed the DoD research program structure and mission are no longer viable in this changing environment. This monograph examines the current organization of the DoD biodefense research program in light of the changing national biodefense landscape and industry best practices, and argues that all aspects of the DoD biodefense program should be consolidated with all other federal biodefense resources, including those within the National Institutes of Health, to create a single, focused, and productive program. This new agency, subordinate to the Department of Health and Human Services, will be positioned and equipped to provide medical solutions to the warfighter on the battlefield, as well as to U.S. citizens.
Book Synopsis USAMRIID's Medical Management of Biological Casualties Handbook by : U.S. Army Medical Research Institute of Infectious Diseases
Download or read book USAMRIID's Medical Management of Biological Casualties Handbook written by U.S. Army Medical Research Institute of Infectious Diseases and published by Imp. This book was released on 2001 with total page 256 pages. Available in PDF, EPUB and Kindle. Book excerpt: The purpose for this handbook is to serve as a concise pocket-sized manual that will guide medical personnel in the prophylaxis and management of biological casulties. It is designed as a quick reference and overview, and is not intended as a definitive text on the medical management of biological casualties.
Book Synopsis Department of Defense Acquisition of Vaccine Production by :
Download or read book Department of Defense Acquisition of Vaccine Production written by and published by . This book was released on 2000 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt: By memorandum dated July 20, 2000, the Deputy Secretary of Defense tasked the Director, Defense Research and Engineering and the Assistant Secretary of Defense for Health Affairs to jointly contract with a private organization or panel of experts to conduct a comprehensive study of the Department of Defense (DoD) acquisition of vaccine production (AVP). The study was to focus on review of the following areas: 1) Vaccines to protect Service members against biological warfare threats as well as infectious diseases. 2) A comparison of current Department efforts with best business practices in the biologics industry, and if/how the Department can leverage the best aspects of the private sector programs from industry. 3) A determination whether the DoD program requires acquisition processes unique from normal departmental acquisition procedures. 4) The development of recommendations for how the Department should best develop and oversee a vaccine production program.
Book Synopsis FDA Regulatory Affairs by : Douglas J. Pisano
Download or read book FDA Regulatory Affairs written by Douglas J. Pisano and published by CRC Press. This book was released on 2008-08-11 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examines harmonization of the US Federal Food, Drug, and Cosmetic Act with international regulations as they apply to human drug and device development, research, manufacturing, and marketing. The Second Edition focuses on the new drug approval process, cGMPs, GCPs, quality system compliance, and corresponding documentation requirements. Written in a jargon-free style, it draws information from a wide range of resources. It demystifies the inner workings of the FDA and facilitates an understanding of how it operates with respect to compliance and product approval. FDA Regulatory Affairs: provides a blueprint to the FDA and drug, biologic, and medical device development offers current, real-time information in a simple and concise format contains a chapter highlighting the new drug application (NDA) process discusses FDA inspection processes and enforcement options includes contributions from experts at companies such as Millennium and Genzyme, leading CRO’s such as PAREXEL and the Biologics Consulting Group, and the FDA Three all-new chapters cover: clinical trial exemptions advisory committees provisions for fast track
