Fda In The Twenty First Century

Author: I. Glenn Cohen
Publisher: Columbia University Press
ISBN: 0231540078
Size: 59.91 MB
Format: PDF, Mobi
View: 228
Download
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, contributors rethink the structure, function, and future of the agency and the effect policy innovations may have on regulatory institutions in other countries.

Postwar America

Author: James Ciment
Publisher: Routledge
ISBN: 1317462351
Size: 41.66 MB
Format: PDF, ePub, Docs
View: 1129
Download
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.

The New Health Bioeconomy

Author: James Mittra
Publisher: Springer
ISBN: 1137430524
Size: 46.29 MB
Format: PDF, ePub
View: 109
Download
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: 15.81 MB
Format: PDF, ePub
View: 7256
Download
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.

Law Religion And Health In The United States

Author: Holly Fernandez Lynch
Publisher: Cambridge University Press
ISBN: 1107164885
Size: 17.79 MB
Format: PDF
View: 6650
Download
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.

Regulatory Breakdown

Author: Cary Coglianese
Publisher: University of Pennsylvania Press
ISBN: 9780812207491
Size: 48.28 MB
Format: PDF, ePub
View: 3374
Download
Regulatory Breakdown: The Crisis of Confidence in U.S. Regulation brings fresh insight and analytic rigor to what has become one of the most contested domains of American domestic politics. Critics from the left blame lax regulation for the housing meltdown and financial crisis—not to mention major public health disasters ranging from the Gulf Coast oil spill to the Upper Big Branch Mine explosion. At the same time, critics on the right disparage an excessively strict and costly regulatory system for hampering economic recovery. With such polarized accounts of regulation and its performance, the nation needs now more than ever the kind of dispassionate, rigorous scholarship found in this book. With chapters written by some of the nation's foremost economists, political scientists, and legal scholars, Regulatory Breakdown brings clarity to the heated debate over regulation by dissecting the disparate causes of the current crisis as well as analyzing promising solutions to what ails the U.S. regulatory system. This volume shows policymakers, researchers, and the public why they need to question conventional wisdom about regulation—whether from the left or the right—and demonstrates the value of undertaking systematic analysis before adopting policy reforms in the wake of disaster.

Food And Drug Regulation In An Era Of Globalized Markets

Author: Sam F Halabi
Publisher: Academic Press
ISBN: 0128025506
Size: 75.59 MB
Format: PDF, ePub, Mobi
View: 803
Download
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

Challenges For The Fda

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 9780309179447
Size: 44.93 MB
Format: PDF, ePub, Mobi
View: 416
Download
As the principal agency regulating food, drugs, medical devices, and biological products used by Americans, the U.S. Food and Drug Administration (FDA) serves one of the most critical consumer protection functions of the federal government. The FDA's reach is enormous, regulating products that represent roughly 25 percent of all consumer spending in the United States. Since 1992, however, federal funding for the agency has diminished, and the FDA's Center for Drug Evaluation and Research (CDER) currently relies on the fees it receives from the industry it regulates to fund the majority of its drug regulation functions. Prescription drug safety is receiving heightened press coverage and congressional scrutiny as a result of recent, highly publicized events, such as the recall of Vioxx because of its link to heart attacks, and the link between certain antidepressants (selective serotonin reuptake inhibitors, or SSRIs) and an increased risk of suicidal ideation in children. To address these concerns, the FDA in 2005 commissioned the Institute of Medicine (IOM) to conduct an independent assessment of the current U.S. drug safety system. In September 2006, the IOM committee released its report-The Future of Drug Safety: Promoting and Protecting the Health of the Public-which included 25 recommendations for improving the system for drug safety review. The committee identified four major vulnerabilities in the U.S. drug safety system: (1) chronic underfunding; (2) organization problems, particularly inadequate integration of pre-and postmarket data review; (3) a range of technical problems related to the insufficient quantity and quality of postmarket data and inadequate capability to systematically monitor the risks and benefits of drugs after marketing; and (4) unclear regulatory authority and insufficiently flexible regulatory tools. Since the IOM report was issued, the FDA has taken a number of steps toward implementing the recommended improvements. Like many government agencies, however, the FDA is financially strained by its existing responsibilities, and fully implementing the recommended improvements to the drug safety system would require significant financial commitments.The IOM report addressed some of the costs associated with its recommendations, but left many unanswered questions about the resources required to fully achieve the envisioned improvements. To better understand the types and magnitude of resources required to achieve the goals of the IOM report, the IOM's Forum on Drug Discovery, Development, and Translation convened a 1-day symposium in March 2007. Challenges for the FDA: The Future of Drug Safety, Workshop Summary explains the presentations and discussions in seven key areas: addressing the FDA's resource challenges; strengthening the scientific base of the agency; integrating pre- and postmarket review; enhancing postmarket safety monitoring; conducting confirmatory drug safety and efficacy studies; enhancing the value of clinical trial registration; and enhancing the FDA's postmarket regulation and enforcement.