FDA IN THE TWENTY FIRST CENTURY THE CHALLENGES OF REGULATING DRUGS AND NEW TECHNOLOGIES

Download Fda In The Twenty First Century The Challenges Of Regulating Drugs And New Technologies ebook PDF or Read Online books in PDF, EPUB, and Mobi Format. Click Download or Read Online button to FDA IN THE TWENTY FIRST CENTURY THE CHALLENGES OF REGULATING DRUGS AND NEW TECHNOLOGIES book pdf for free now.

Fda In The Twenty First Century

Author : Holly Fernandez Lynch
ISBN : 9780231540070
Genre : Business & Economics
File Size : 62.49 MB
Format : PDF, Kindle
Download : 260
Read : 215

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.
Category: Business & Economics

Protecting America S Health

Author : Philip J. Hilts
ISBN : 0807855820
Genre : Medical
File Size : 68.26 MB
Format : PDF, Mobi
Download : 876
Read : 735

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.
Category: Medical

Postwar America

Author : James Ciment
ISBN : 9781317462354
Genre : Business & Economics
File Size : 61.87 MB
Format : PDF
Download : 323
Read : 666

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.
Category: Business & Economics

The New Health Bioeconomy

Author : James Mittra
ISBN : 9781137430526
Genre : Social Science
File Size : 71.29 MB
Format : PDF, Docs
Download : 207
Read : 395

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.
Category: Social Science

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

Author : Jean-Paul Gaudillière
ISBN : 9781137291523
Genre : History
File Size : 75.69 MB
Format : PDF, Docs
Download : 598
Read : 790

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.
Category: History

Law And The Technologies Of The Twenty First Century

Author : Roger Brownsword
ISBN : 9780521186247
Genre : Law
File Size : 36.61 MB
Format : PDF, ePub, Docs
Download : 981
Read : 539

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.
Category: Law

The Cure In The Code

Author : Peter W. Huber
ISBN : 9780465069811
Genre : Law
File Size : 88.40 MB
Format : PDF, Docs
Download : 322
Read : 1165

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.
Category: Law

Prometheus Reimagined

Author : Albert C Lin
ISBN : 9780472029242
Genre : Law
File Size : 39.68 MB
Format : PDF
Download : 554
Read : 587

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.
Category: Law

Food And Drug Regulation In An Era Of Globalized Markets

Author : Sam F Halabi
ISBN : 9780128025505
Genre : Technology & Engineering
File Size : 21.50 MB
Format : PDF, ePub
Download : 146
Read : 520

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
Category: Technology & Engineering

Challenges For The Fda

Author : Institute of Medicine
ISBN : 0309179440
Genre : Medical
File Size : 40.66 MB
Format : PDF, Kindle
Download : 233
Read : 736

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.
Category: Medical