Fda in the Twenty-First Century

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Opis: Fda in the Twenty-First Century

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. This book contains a concise historical account of FDA regulation and an insightful analysis of the major challenges the FDA faces over the next quarter century. The contributors, drawn from a variety of fields, are all authorities on the issues at hand. Although they do not share the same opinions, their disagreements make this essay collection remarkably balanced. Essential reading. -- Anup Malani, University of Chicago A truly magisterial collection, FDA in the Twenty-First Century is a must-read for academics, practitioners, and social scientists interested in the future of drug and device regulation. The book's contributors offer thoughtful and well-researched policy approaches on conundrums facing the FDA and similar agencies around the world. Bravo! -- Frank Pasquale, University of Maryland, Carey School of Law This insightful and informative book draws on a variety of perspectives to chart a course for the FDA-and society-as we confront the challenges of medical-product regulation in the twenty-first century. It should be read by regulators and the regulated alike, as well as by patients, policy makers, payers, physicians, pharmacists-anyone interested in human health. -- Daniel Troy, general counsel, GlaxoSmithKline PLC, and chief counsel of the FDA from 2001 to 2004 FDA in the Twenty-First Century lives up to its title. Drawing on the historical evolution of the FDA, this book lays out, in a clear and thoughtful manner, key questions for the future. At a time when scientific opportunities are presenting at lightning speed and the expectations of the public for transparency, personalized medicine, and safety have never been greater, this is an important book. -- Amy Rick, Food and Drug Law InstituteAcknowledgmentsIntroduction, by Holly Fernandez Lynch and I. Glenn Cohen1. Historical Themes and Developments at FDA Over the Past Fifty Years, by Peter Barton HuttPart 1. FDA in a Changing WorldIntroduction, by Holly Fernandez Lynch2. A Global and Innovative Regulatory Environment for the U.S. FDA, by Howard Sklamberg and Jennifer Devine3. FDA and the Rise of the Empowered Patient, by Lewis A. Grossman4. After the FDA: A Twentieth-Century Agency in a Postmodern World, by Theodore W. Ruger5. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007, by Barbara J. EvansPart 2. Preserving Public Trust and Demanding AccountabilityIntroduction, by Christopher Robertson6. Global Trends Toward Transparency in Participant-Level Clinical Trials Data, by Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer7. Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties, by Genevieve Pham-Kanter8. The Crime of Being in Charge: Executive Culpability and Collateral Consequences, by Katrice Bridges Copeland9. Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health, by Patrick O'LearyPart 3. Protecting the Public Within Constitutional LimitsIntroduction, by Glenn Cohen10. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, by Aaron S. Kesselheim and Michelle M. Mello11. The FDCA as the Test for Truth of Promotional Claims, by Christopher Robertson12. Why FDA's Ban on Off-Label Promotion Violates the First Amendment: A Study in the Values of Commercial Speech Protection, by Coleen Klasmeier and Martin H. RedishPart 4. Timing Is Everything: Balancing Access and UncertaintyIntroduction, by W. Nicholson Price II13. Speed Versus Safety in Drug Development, by R. Alta Charo14. Overcoming "Premarket Syndrome": Promoting Better Postmarket Surveillance in an Evolving Drug Development Context, by Shannon Gibson and Trudo Lemmens15. FDA's Public Health Imperative: An Increased Role for Active Postmarket Analysis, by Efthimios ParasidisPart 5. Old and New Issues in Drug RegulationIntroduction, by R. Alta Charo16. The Drug Efficacy Study and Its Manifold Legacies, by Daniel Carpenter, Jeremy Greene, and Susan Moffitt17. Drug Safety Communication: The Evolving Environment, by Geoffrey Levitt18. Innovation Policy Failures in the Manufacturing of Drugs, by W. Nicholson Price IIPart 6. Regulatory Exclusivities and the Regulation of Generic Drugs and BiosimilarsIntroduction, by Benjamin N. Roin19. From "Recycled Molecule" to Orphan Drug: Lessons from Makena, by Kate Greenwood20. FDA, Negotiated Rule Making, and Generics: A Proposal, by Marie Boyd21. The "Follow-On" Challenge: Statutory Exclusivities and Patent Dances, by Arti Rai22. FDA Regulation of Biosimilars, by Henry Grabowski and Erika LietzanPart 7. New Wine in Old Bottles: FDA's Role in Regulating New TechnologiesIntroduction, by Frances H. Miller23. Analog Agency in a Digital World, by Nathan Cortez24. Twenty-First-Century Technology with Twentieth-Century Baggage: FDA Regulation of Regenerative Medicine, by Margaret Foster Riley25. Device-ive Maneuvers: FDA's Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing, by Elizabeth R. Pike and Kayte Spector-Bagdady26. A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records, by Andrew English, David Rosenberg, and Huaou Yan27. Race and the FDA, by Jonathan KahnContributorsIndex


Szczegóły: Fda in the Twenty-First Century

Tytuł: Fda in the Twenty-First Century
Producent: Columbia University Press
ISBN: 9780231171182
Rok produkcji: 2015
Ilość stron: 568
Oprawa: Twarda
Waga: 0.45 kg


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Fda in the Twenty-First Century

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. This book contains a concise historical account of FDA regulation and an insightful analysis of the major challenges the FDA faces over the next quarter century. The contributors, drawn from a variety of fields, are all authorities on the issues at hand. Although they do not share the same opinions, their disagreements make this essay collection remarkably balanced. Essential reading. -- Anup Malani, University of Chicago A truly magisterial collection, FDA in the Twenty-First Century is a must-read for academics, practitioners, and social scientists interested in the future of drug and device regulation. The book's contributors offer thoughtful and well-researched policy approaches on conundrums facing the FDA and similar agencies around the world. Bravo! -- Frank Pasquale, University of Maryland, Carey School of Law This insightful and informative book draws on a variety of perspectives to chart a course for the FDA-and society-as we confront the challenges of medical-product regulation in the twenty-first century. It should be read by regulators and the regulated alike, as well as by patients, policy makers, payers, physicians, pharmacists-anyone interested in human health. -- Daniel Troy, general counsel, GlaxoSmithKline PLC, and chief counsel of the FDA from 2001 to 2004 FDA in the Twenty-First Century lives up to its title. Drawing on the historical evolution of the FDA, this book lays out, in a clear and thoughtful manner, key questions for the future. At a time when scientific opportunities are presenting at lightning speed and the expectations of the public for transparency, personalized medicine, and safety have never been greater, this is an important book. -- Amy Rick, Food and Drug Law InstituteAcknowledgmentsIntroduction, by Holly Fernandez Lynch and I. Glenn Cohen1. Historical Themes and Developments at FDA Over the Past Fifty Years, by Peter Barton HuttPart 1. FDA in a Changing WorldIntroduction, by Holly Fernandez Lynch2. A Global and Innovative Regulatory Environment for the U.S. FDA, by Howard Sklamberg and Jennifer Devine3. FDA and the Rise of the Empowered Patient, by Lewis A. Grossman4. After the FDA: A Twentieth-Century Agency in a Postmodern World, by Theodore W. Ruger5. The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007, by Barbara J. EvansPart 2. Preserving Public Trust and Demanding AccountabilityIntroduction, by Christopher Robertson6. Global Trends Toward Transparency in Participant-Level Clinical Trials Data, by Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer7. Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties, by Genevieve Pham-Kanter8. The Crime of Being in Charge: Executive Culpability and Collateral Consequences, by Katrice Bridges Copeland9. Recalibrating Enforcement in the Biomedical Industry: Deterrence and the Primacy of Protecting the Public Health, by Patrick O'LearyPart 3. Protecting the Public Within Constitutional LimitsIntroduction, by Glenn Cohen10. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, by Aaron S. Kesselheim and Michelle M. Mello11. The FDCA as the Test for Truth of Promotional Claims, by Christopher Robertson12. Why FDA's Ban on Off-Label Promotion Violates the First Amendment: A Study in the Values of Commercial Speech Protection, by Coleen Klasmeier and Martin H. RedishPart 4. Timing Is Everything: Balancing Access and UncertaintyIntroduction, by W. Nicholson Price II13. Speed Versus Safety in Drug Development, by R. Alta Charo14. Overcoming "Premarket Syndrome": Promoting Better Postmarket Surveillance in an Evolving Drug Development Context, by Shannon Gibson and Trudo Lemmens15. FDA's Public Health Imperative: An Increased Role for Active Postmarket Analysis, by Efthimios ParasidisPart 5. Old and New Issues in Drug RegulationIntroduction, by R. Alta Charo16. The Drug Efficacy Study and Its Manifold Legacies, by Daniel Carpenter, Jeremy Greene, and Susan Moffitt17. Drug Safety Communication: The Evolving Environment, by Geoffrey Levitt18. Innovation Policy Failures in the Manufacturing of Drugs, by W. Nicholson Price IIPart 6. Regulatory Exclusivities and the Regulation of Generic Drugs and BiosimilarsIntroduction, by Benjamin N. Roin19. From "Recycled Molecule" to Orphan Drug: Lessons from Makena, by Kate Greenwood20. FDA, Negotiated Rule Making, and Generics: A Proposal, by Marie Boyd21. The "Follow-On" Challenge: Statutory Exclusivities and Patent Dances, by Arti Rai22. FDA Regulation of Biosimilars, by Henry Grabowski and Erika LietzanPart 7. New Wine in Old Bottles: FDA's Role in Regulating New TechnologiesIntroduction, by Frances H. Miller23. Analog Agency in a Digital World, by Nathan Cortez24. Twenty-First-Century Technology with Twentieth-Century Baggage: FDA Regulation of Regenerative Medicine, by Margaret Foster Riley25. Device-ive Maneuvers: FDA's Risk Assessment of Bifurcated Direct-to-Consumer Genetic Testing, by Elizabeth R. Pike and Kayte Spector-Bagdady26. A New Regulatory Function for E-Prescriptions: Linking FDA to Physicians and Patient Records, by Andrew English, David Rosenberg, and Huaou Yan27. Race and the FDA, by Jonathan KahnContributorsIndex

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Cena 280,00 PLN
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Wysyłka: Niedostępna
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Szczegóły: Fda in the Twenty-First Century

Tytuł: Fda in the Twenty-First Century
Producent: Columbia University Press
ISBN: 9780231171182
Rok produkcji: 2015
Ilość stron: 568
Oprawa: Twarda
Waga: 0.45 kg


Recenzje: Fda in the Twenty-First Century

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