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Author :
Publisher :
ISBN 13 :
Total Pages : 1096 pages
Book Rating : 4.3/5 (121 download)
Download or read book Code of Federal Regulations written by and published by . This book was released on 2007 with total page 1096 pages. Available in PDF, EPUB and Kindle. Book excerpt: Special edition of the Federal register. Subject/agency index for rules codified in the Code of Federal Regulations, revised as of Jan. 1 ...
Author : National Research Council
Publisher : National Academies Press
ISBN 13 : 0309163587
Total Pages : 589 pages
Book Rating : 4.3/5 (91 download)
Download or read book Enhancing Food Safety written by National Research Council and published by National Academies Press. This book was released on 2010-11-04 with total page 589 pages. Available in PDF, EPUB and Kindle. Book excerpt: Recent outbreaks of illnesses traced to contaminated sprouts and lettuce illustrate the holes that exist in the system for monitoring problems and preventing foodborne diseases. Although it is not solely responsible for ensuring the safety of the nation's food supply, the U.S. Food and Drug Administration (FDA) oversees monitoring and intervention for 80 percent of the food supply. The U.S. Food and Drug Administration's abilities to discover potential threats to food safety and prevent outbreaks of foodborne illness are hampered by impediments to efficient use of its limited resources and a piecemeal approach to gathering and using information on risks. Enhancing Food Safety: The Role of the Food and Drug Administration, a new book from the Institute of Medicine and the National Research Council, responds to a congressional request for recommendations on how to close gaps in FDA's food safety systems. Enhancing Food Safety begins with a brief review of the Food Protection Plan (FPP), FDA's food safety philosophy developed in 2007. The lack of sufficient detail and specific strategies in the FPP renders it ineffectual. The book stresses the need for FPP to evolve and be supported by the type of strategic planning described in these pages. It also explores the development and implementation of a stronger, more effective food safety system built on a risk-based approach to food safety management. Conclusions and recommendations include adopting a risk-based decision-making approach to food safety; creating a data surveillance and research infrastructure; integrating federal, state, and local government food safety programs; enhancing efficiency of inspections; and more. Although food safety is the responsibility of everyone, from producers to consumers, the FDA and other regulatory agencies have an essential role. In many instances, the FDA must carry out this responsibility against a backdrop of multiple stakeholder interests, inadequate resources, and competing priorities. Of interest to the food production industry, consumer advocacy groups, health care professionals, and others, Enhancing Food Safety provides the FDA and Congress with a course of action that will enable the agency to become more efficient and effective in carrying out its food safety mission in a rapidly changing world.
Author : Office of the Federal Register
Publisher :
ISBN 13 : 9781609465926
Total Pages : 357 pages
Book Rating : 4.4/5 (659 download)
Download or read book Food and Drugs, Parts 1300 to End written by Office of the Federal Register and published by . This book was released on 2012-06 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: Title 21 presents regulations promulgated by the Food and Drug Administration, the Drug Enforcement Administration, and the Office of the National Drug Control Agency in the area of food and drugs. These regulations encompass food and drugs for human and animal use, biologics, cosmetics, medical devices, radiological health, and controlled substances. Additions and revisions to this section of the code are posted annually by April. Publication follows within six months.
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)
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.
Author :
Publisher :
ISBN 13 :
Total Pages : 202 pages
Book Rating : 4.3/5 (91 download)
Download or read book Code of Federal Regulations written by and published by . This book was released on 1997 with total page 202 pages. Available in PDF, EPUB and Kindle. Book excerpt: Special edition of the Federal Register, containing a codification of documents of general applicability and future effect ... with ancillaries.
Author :
Publisher :
ISBN 13 :
Total Pages : 468 pages
Book Rating : 4.F/5 ( download)
Download or read book The Code of Federal Regulations of the United States of America written by and published by . This book was released on 1997 with total page 468 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Code of Federal Regulations is the codification of the general and permanent rules published in the Federal Register by the executive departments and agencies of the Federal Government.
Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309158060
Total Pages : 442 pages
Book Rating : 4.3/5 (91 download)
Download or read book Rare Diseases and Orphan Products written by Institute of Medicine and published by National Academies Press. This book was released on 2011-04-03 with total page 442 pages. Available in PDF, EPUB and Kindle. Book excerpt: Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Author : U. s. Government Printing Office
Publisher : Government Printing Office
ISBN 13 : 9780160907210
Total Pages : 372 pages
Book Rating : 4.9/5 (72 download)
Download or read book Food and Drugs, Part 1300 to End written by U. s. Government Printing Office and published by Government Printing Office. This book was released on 2012-07-09 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 :
Total Pages : 24 pages
Book Rating : 4.:/5 (319 download)
Download or read book A Small Business Guide to FDA. written by and published by . This book was released on 1982 with total page 24 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Curtis L. Meinert
Publisher : John Wiley & Sons
ISBN 13 : 1118315286
Total Pages : 449 pages
Book Rating : 4.1/5 (183 download)
Download or read book Clinical Trials Dictionary written by Curtis L. Meinert and published by John Wiley & Sons. This book was released on 2012-08-15 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: A thoroughly updated new edition of the essential reference on the design, practice, and analysis of clinical trials Clinical Trials Dictionary: Terminology and Usage Recommendations, Second Edition presents clear, precise, meticulously detailed entries on all aspects of modern-day clinical trials. Written and compiled by one of the world’s leading clinical trialists, this comprehensive volume incorporates areas of medicine, statistics, epidemiology, computer science, and bioethics—providing a treasure trove of key terms and ideas. This new edition continues to supply readers with the A–Z terminology needed to design, conduct, and analyze trials, introducing a vocabulary for the characterization and description of related features and activities. More than 300 new entries are now included, reflecting the current usage practices and conventions in the field, along with usage notes with recommendations on when to use the term in question. Detailed biographical notes highlight prominent historical figures and institutions in the field, and an extensive bibliography has been updated to provide readers with additional resources for further study. The most up-to-date work of its kind, Clinical Trials Dictionary, Second Edition is an essential reference for anyone who needs to report on, index, analyze, or assess the scientific strength and validity of clinical trials.
Author : Dragan Primorac
Publisher : CRC Press
ISBN 13 : 146656914X
Total Pages : 494 pages
Book Rating : 4.4/5 (665 download)
Download or read book Design of Biomedical Devices and Systems written by Dragan Primorac and published by CRC Press. This book was released on 2014-07-29 with total page 494 pages. Available in PDF, EPUB and Kindle. Book excerpt: Apply a Wide Variety of Design Processes to a Wide Category of Design Problems Design of Biomedical Devices and Systems, Third Edition continues to provide a real-world approach to the design of biomedical engineering devices and/or systems. Bringing together information on the design and initiation of design projects from several sources, this edition strongly emphasizes and further clarifies the standards of design procedure. Following the best practices for conducting and completing a design project, it outlines the various steps in the design process in a basic, flexible, and logical order. What’s New in the Third Edition: This latest edition contains a new chapter on biological engineering design, a new chapter on the FDA regulations for items other than devices such as drugs, new end-of-chapter problems, new case studies, and a chapter on product development. It adds mathematical modeling tools, and provides new information on FDA regulations and standards, as well as clinical trials and sterilization methods. Familiarizes the reader with medical devices, and their design, regulation, and use Considers safety aspects of the devices Contains an enhanced pedagogy Provides an overview of basic design issues Design of Biomedical Devices and Systems, Third Edition covers the design of biomedical engineering devices and/or systems, and is designed to support bioengineering and biomedical engineering students and novice engineers entering the medical device market.
Author : Paul H. King
Publisher : CRC Press
ISBN 13 : 0429786069
Total Pages : 508 pages
Book Rating : 4.4/5 (297 download)
Download or read book Design of Biomedical Devices and Systems, 4th edition written by Paul H. King and published by CRC Press. This book was released on 2018-10-03 with total page 508 pages. Available in PDF, EPUB and Kindle. Book excerpt: This fourth edition is a substantial revision of a highly regarded text, intended for senior design capstone courses within departments of biomedical engineering, bioengineering, biological engineering and medical engineering, worldwide. Each chapter has been thoroughly updated and revised to reflect the latest developments. New material has been added on entrepreneurship, bioengineering design, clinical trials and CRISPR. Based upon feedback from prior users and reviews, additional and new examples and applications, such as 3D printing have been added to the text. Additional clinical applications were added to enhance the overall relevance of the material presented. Relevant FDA regulations and how they impact the designer’s work have been updated. Features Provides updated material as needed to each chapter Incorporates new examples and applications within each chapter Discusses new material related to entrepreneurship, clinical trials and CRISPR Relates critical new information pertaining to FDA regulations. Presents new material on "discovery" of projects "worth pursuing" and design for health care for low-resource environments Presents multiple case examples of entrepreneurship in this field Addresses multiple safety and ethical concerns for the design of medical devices and processes
Author : Paul H. King
Publisher : CRC Press
ISBN 13 : 1439878072
Total Pages : 424 pages
Book Rating : 4.4/5 (398 download)
Download or read book Design of Biomedical Devices and Systems Second edition written by Paul H. King and published by CRC Press. This book was released on 2008-08-22 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: The design and functional complexity of medical devices and systems has increased during the past half century, evolving from the level of cardiac pacemakers to magnetic resonance imaging devices. Such life-saving advancements are monumentally advantageous, but with so much at stake, a step-by-step manual for biomedical engineers is essential. This
Author :
Publisher : Office of the Federal Register
ISBN 13 : 9780160883972
Total Pages : 252 pages
Book Rating : 4.8/5 (839 download)
Download or read book Food and Drugs written by and published by Office of the Federal Register. This book was released on 2011-06-28 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : United States. Federal Trade Commission. Bureau of Consumer Protection
Publisher :
ISBN 13 :
Total Pages : 32 pages
Book Rating : 4.:/5 (31 download)
Download or read book Dietary Supplements written by United States. Federal Trade Commission. Bureau of Consumer Protection and published by . This book was released on 1998 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Suzanne H. Reuben
Publisher : DIANE Publishing
ISBN 13 : 1437934218
Total Pages : 240 pages
Book Rating : 4.4/5 (379 download)
Download or read book Reducing Environmental Cancer Risk written by Suzanne H. Reuben and published by DIANE Publishing. This book was released on 2010-10 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: Though overall cancer incidence and mortality have continued to decline in recent years, cancer continues to devastate the lives of far too many Americans. In 2009 alone, 1.5 million American men, women, and children were diagnosed with cancer, and 562,000 died from the disease. There is a growing body of evidence linking environmental exposures to cancer. The Pres. Cancer Panel dedicated its 2008¿2009 activities to examining the impact of environmental factors on cancer risk. The Panel considered industrial, occupational, and agricultural exposures as well as exposures related to medical practice, military activities, modern lifestyles, and natural sources. This report presents the Panel¿s recommend. to mitigate or eliminate these barriers. Illus.
Author : Michael McGuffin
Publisher : American Herbal Products Assocation
ISBN 13 : 9780967871905
Total Pages : 421 pages
Book Rating : 4.8/5 (719 download)
Download or read book Herbs of Commerce written by Michael McGuffin and published by American Herbal Products Assocation. This book was released on 2001-10-01 with total page 421 pages. Available in PDF, EPUB and Kindle. Book excerpt:
