Fda In The Twenty First Century

Author: Holly Fernandez Lynch
Publisher: Columbia University Press
ISBN: 0231540078
Size: 37.94 MB
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In its decades-long effort to assure the safety, efficacy, and security of medicines and other products, the Food and Drug Administration has struggled with issues of funding, proper associations with industry, and the balance between consumer choice and consumer protection. Today, these challenges are compounded by the pressures of globalization, the introduction of novel technologies, and fast-evolving threats to public health. With essays by leading scholars and government and private-industry experts, FDA in the Twenty-First Century addresses perennial and new problems and the improvements the agency can make to better serve the public good. The collection features essays on effective regulation in an era of globalization, consumer empowerment, and comparative effectiveness, as well as questions of data transparency, conflicts of interest, industry responsibility, and innovation policy, all with an emphasis on pharmaceuticals. The book also intervenes in the debate over off-label drug marketing and the proper role of the FDA before and after a drug goes on the market. Dealing honestly and thoroughly with the FDA's successes and failures, these essays rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions abroad.

Postwar America

Author: James Ciment
Publisher: Routledge
ISBN: 1317462351
Size: 54.68 MB
Format: PDF
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From the outbreak of the Cold War to the rise of the United States as the last remaining superpower, the years following World War II were filled with momentous events and rapid change. Diplomatically, economically, politically, and culturally, the United States became a major influence around the globe. On the domestic front, this period witnessed some of the most turbulent and prosperous years in American history. "Postwar America: An Encyclopedia of Social, Political, Cultural, and Economic History" provides detailed coverage of all the remarkable developments within the United States during this period, as well as their dramatic impact on the rest of the world. A-Z entries address specific persons, groups, concepts, events, geographical locations, organizations, and cultural and technological phenomena. Sidebars highlight primary source materials, items of special interest, statistical data, and other information; and Cultural Landmark entries chronologically detail the music, literature, arts, and cultural history of the era. Bibliographies covering literature from the postwar era and about the era are also included, as are illustrations and specialized indexes.

Protecting America S Health

Author: Philip J. Hilts
Publisher: UNC Press Books
ISBN: 9780807855829
Size: 46.21 MB
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Emerging out of Theodore Roosevelt's desire to civilize capitalism, the Food and Drug Administration was created to stop the trade in adulterated meats and quack drugs. This history of the agency takes readers back to its beginnings, and makes startlingly clear the essential role the FDA has played in maintaining the quality of life and health to which the American public has long been accustomed.

The New Health Bioeconomy

Author: James Mittra
Publisher: Springer
ISBN: 1137430524
Size: 44.54 MB
Format: PDF, Kindle
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This book provides new insights into how new biology, and the emergence of "translational" policies to drive the health bioeconomy, is reshaping the innovation ecosystem for new therapies. A key argument is that a broader definition of value (beyond the economic aspects) is needed to understand health innovation in the twenty-first century.

Law And The Technologies Of The Twenty First Century

Author: Roger Brownsword
Publisher: Cambridge University Press
ISBN: 0521186242
Size: 64.42 MB
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A clear and comprehensive introduction for students studying key regulatory challenges posed by technologies in the twenty-first century. Co-authored by a leading scholar in the field with a new scholar to the area, it combines comprehensive knowledge with a fresh perspective. Essential reading for students of law and technology.

Food And Drug Regulation In An Era Of Globalized Markets

Author: Sam F Halabi
Publisher: Academic Press
ISBN: 0128025506
Size: 64.86 MB
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Food and Drug Regulation in an Era of Globalized Markets provides a synthesized look at the pressures that are impacting today’s markets, including trade liberalization, harmonization initiatives between governments, increased aid activities to low-and middle-income countries, and developing pharmaceutical sectors in China and India. From the changing nature of packaged and processed food supply chains, to the reorientation of pharmaceutical research and funding coalesced to confront firms, regulators, and consumers are now faced with previously unknown challenges. Based on the 2014 O’Neill Institute Summer program, this book provides an international, cross-disciplinary look at the changing world of regulations and offers insights into requirements for successful implementation. Interdisciplinary approach allows readers to understand the varying perspectives involved in regulatory development Includes case studies to highlight harmonization efforts and challenges, and to provide practical insights for application going forward Provides a thorough assessment of supply chains, potential gaps, and means of anticipating and addressing issues Presents a comprehensive snapshot of changes in the food safety law in the United States and under international standards, including academic, industry and regulatory perspectives Addresses conflicts and cooperation between relevant US agencies including USDA, FDA, DEA, EPA, FTC and the Department of Commerce

Prometheus Reimagined

Author: Albert C Lin
Publisher: University of Michigan Press
ISBN: 047202924X
Size: 75.29 MB
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Technologies such as synthetic biology, nanotechnology, artificial intelligence, and geoengineering promise to address many of our most serious problems, yet they also bring environmental and health-related risks and uncertainties. Moreover, they can come to dominate global production systems and markets with very little public input or awareness. Existing governance institutions and processes do not adequately address the risks of new technologies, nor do they give much consideration to the concerns of persons affected by them. Instead of treating technology, health, and the environment as discrete issues, Albert C. Lin argues that laws must acknowledge their fundamental relationship, anticipating both future technological developments and their potential adverse effects. Laws should encourage international cooperation and the development of common global standards, while allowing for flexibility and reassessment.

The Cure In The Code

Author: Peter W. Huber
Publisher: Basic Books
ISBN: 0465069819
Size: 35.10 MB
Format: PDF
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Never before have two revolutions with so much potential to save and prolong human life occurred simultaneously. The converging, synergistic power of the biochemical and digital revolutions now allows us to read every letter of life's code, create precisely targeted drugs to control it, and tailor their use to individual patients. Cancer, diabetes, Alzheimer's and countless other killers can be vanquished—if we make full use of the tools of modern drug design and allow doctors the use of modern data gathering and analytical tools when prescribing drugs to their patients. But Washington stands in the way, clinging to outdated drug-approval protocols developed decades ago during medicine's long battle with the infectious epidemics of the past. Peter Huber, an expert in science, technology, and public policy, demonstrates why Washington's one-size-fits-all drug policies can't deal with diseases rooted in the complex molecular diversity of human bodies. Washington is ill-equipped to handle the torrents of data that now propel the advance of molecular medicine and is reluctant to embrace the statistical methods of the digital age that can. Obsolete economic policies, often rationalized as cost-saving measures, stifle innovation and suppress investment in the medicine that can provide the best cures at the lowest cost. In the 1980s, an AIDS diagnosis was a death sentence, until the FDA loosened its throttling grip and began streamlining and accelerating approval of life-saving drugs. The Cure in the Code shows patients, doctors, investors, and policy makers what we must now do to capture the full life-saving and cost-saving potential of the revolution in molecular medicine. America has to choose. At stake for America is the power to lead the world in mastering the most free, fecund, competitive, dynamic, and intelligent natural resource on the planet—the molecular code that spawns human life and controls our health.

Law Religion And Health In The United States

Author: Holly Fernandez Lynch
Publisher: Cambridge University Press
ISBN: 1107164885
Size: 32.38 MB
Format: PDF, ePub
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While the law can create conflict between religion and health, it can also facilitate religious accommodation and protection of conscience. Finding this balance is critical to addressing the most pressing questions at the intersection of law, religion, and health in the United States: should physicians be required to disclose their religious beliefs to patients? How should we think about institutional conscience in the health care setting? How should health care providers deal with families with religious objections to withdrawing treatment? In this timely book, experts from a variety of perspectives and disciplines offer insight on these and other pressing questions, describing what the public discourse gets right and wrong, how policymakers might respond, and what potential conflicts may arise in the future. It should be read by academics, policymakers, and anyone else - patient or physician, secular or devout - interested in how US law interacts with health care and religion.

Ways Of Regulating Drugs In The 19th And 20th Centuries

Author: Jean-Paul Gaudillière
Publisher: Springer
ISBN: 1137291524
Size: 77.50 MB
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This collection takes the perspective that the historiography of science, technology, and medicine needs a broader approach toward regulation. The authors explore the distinct social worlds involved in regulation, the forms of evidence and expertise mobilized, and means of intervention chosen to tame drugs in factories, consulting rooms and courts.