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Author: Richard Kingham (Lawyer)
Publisher:
ISBN: 9781838624767
Category :
Languages : en
Pages :
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Book Description
Author: Richard Kingham (Lawyer)
Publisher:
ISBN: 9781838624767
Category :
Languages : en
Pages :
Get Book
Book Description
Author: Richard Kingham (Lawyer)
Publisher:
ISBN: 9781909830400
Category : Biotechnology
Languages : en
Pages : 618
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Book Description
Author:
Publisher:
ISBN: 9781630440176
Category :
Languages : en
Pages :
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Book Description
The Fundamentals of Life Sciences Law: Drugs, Devices, and Biotech, Second Edition, provides a solid grounding in the legal principles and issues inherent in this complex area. Both new practitioners and experienced attorneys alike will benefit from this unparalleled coverage.This new edition features contributions from some of the most experienced and respected practitioners of life sciences and health law. Whether you're looking for an introduction to this area, or you need a go-to reference on your shelf, the coverage includes:Regulation of DrugsRegulation of Medical DevicesRegulation of BiologicsClinical TrialsFraud and AbuseFederal AgenciesRegulation of Advertising, and Promotion of Drugs, Medical Devices, and BiologicsAntitrustPrivacyState RegulationIntellectual PropertyPayment and ReimbursementInternational IssuesLife Sciences Licensing Transaction
Author: David J. Bloch
Publisher:
ISBN:
Category : Biotechnology
Languages : en
Pages : 540
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Book Description
Author: National Academies of Sciences, Engineering, and Medicine
Publisher: National Academies Press
ISBN: 0309458889
Category : Science
Languages : en
Pages : 115
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Book Description
The potential misuse of advances in life sciences research is raising concerns about national security threats. Dual Use Research of Concern in the Life Sciences: Current Issues and Controversies examines the U.S. strategy for reducing biosecurity risks in life sciences research and considers mechanisms that would allow researchers to manage the dissemination of the results of research while mitigating the potential for harm to national security.
Author: Kristian A. Werling
Publisher:
ISBN: 9781630440152
Category : Biotechnology
Languages : en
Pages : 470
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Book Description
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309089778
Category : Technology & Engineering
Languages : en
Pages : 164
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Book Description
In recent years much has happened to justify an examination of biological research in light of national security concerns. The destructive application of biotechnology research includes activities such as spreading common pathogens or transforming them into even more lethal forms. Policymakers and the scientific community at large must put forth a vigorous and immediate response to this challenge. This new book by the National Research Council recommends that the government expand existing regulations and rely on self-governance by scientists rather than adopt intrusive new policies. One key recommendation of the report is that the government should not attempt to regulate scientific publishing but should trust scientists and journals to screen their papers for security risks, a task some journals have already taken up. With biological information and tools widely distributed, regulating only U.S. researchers would have little effect. A new International Forum on Biosecurity should encourage the adoption of similar measures around the world. Seven types of risky studies would require approval by the Institutional Biosafety Committees that already oversee recombinant DNA research at some 400 U.S. institutions. These "experiments of concern" include making an infectious agent more lethal and rendering vaccines powerless.
Author: Roseann B. Termini
Publisher: Forti Publications
ISBN: 9780972989190
Category : Biologicals
Languages : en
Pages : 0
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Book Description
Life Sciences Law: Federal Regulation of Drugs, Biologics, Medical Devices, Foods and Dietary Supplements 4th Edition, focuses on the most up-to-date issues and legal cases in food and drug law. This resource imparts a comprehensive analysis of food and drug law topics and the federal agencies that regulate this industry. The United States Food and Drug Administration’s (FDA) mission, in accordance with the Federal Food, Drug and Cosmetic Act (FDCA), is to protect the public health and safety. Human and Veterinary Drugs, Biologics, Medical Devices, Radiation Emitting Products, Cosmetics, Food, Tobacco and Dietary Supplements, Enforcement and ethical issues are covered. Each chapter contains introductory chapter highlights as well as overviews throughout. Landmark legal decisions are included as well as critical analysis issues to explore. There is a separate CD: Food and Drug Act, Related Laws, Websites and FDA Resources and a separate Instructor’s Manual in CD format.
Author: Robert P. Charrow
Publisher: University of Chicago Press
ISBN: 0226101665
Category : Science
Languages : en
Pages : 342
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Book Description
The National Institutes of Health and the National Science Foundation together fund more than $40 billon of research annually in the United States and around the globe. These large public expenditures come with strings, including a complex set of laws and guidelines that regulate how scientists may use NIH and NSF funds, how federally funded research may be conducted, and who may have access to or own the product of the research. Until now, researchers have had little instruction on the nature of these laws and how they work. But now, with Robert P. Charrow’s Law in the Laboratory, they have a readable and entertaining introduction to the major ethical and legal considerations pertaining to research under the aegis of federal science funding. For any academic whose position is grant funded, or for any faculty involved in securing grants, this book will be an essential reference manual. And for those who want to learn how federal legislation and regulations affect laboratory research, Charrow’s primer will shed light on the often obscured intersection of government and science.
Author: American Health Lawyers Association
Publisher:
ISBN: 9781422439746
Category :
Languages : en
Pages :
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Book Description
