The Resource FDA in the twenty-first century : the challenges of regulating drugs and new technologies, edited by Holly Fernandez Lynch and I. Glenn Cohen

FDA in the twenty-first century : the challenges of regulating drugs and new technologies, edited by Holly Fernandez Lynch and I. Glenn Cohen

Label
FDA in the twenty-first century : the challenges of regulating drugs and new technologies
Title
FDA in the twenty-first century
Title remainder
the challenges of regulating drugs and new technologies
Statement of responsibility
edited by Holly Fernandez Lynch and I. Glenn Cohen
Contributor
Editor
Subject
Genre
Language
  • eng
  • eng
Summary
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
Cataloging source
MiAaPQ
Dewey number
363.19/20973
Index
index present
Language note
English
LC call number
KF3871
LC item number
.F33 2015
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
http://library.link/vocab/relatedWorkOrContributorName
  • Lynch, Holly Fernandez
  • Cohen, I. Glenn
http://library.link/vocab/subjectName
  • United States
  • Drugs
Label
FDA in the twenty-first century : the challenges of regulating drugs and new technologies, edited by Holly Fernandez Lynch and I. Glenn Cohen
Instantiates
Publication
Copyright
Note
Description based upon print version of record
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Content category
text
Content type code
txt
Contents
  • Table of Contents; Acknowledgments; Introduction, by Holly Fernandez Lynch and I. Glenn Cohen; 1. Historical Themes and Developments at FDA Over the Past Fifty Years, by Peter Barton Hutt; Part 1. FDA in a Changing World; Introduction, by Holly Fernandez Lynch; 2. A Global and Innovative Regulatory Environment for the U.S. FDA, by Howard Sklamberg and Jennifer Devine; 3. FDA and the Rise of the Empowered Patient, by Lewis A. Grossman; 4. After the FDA: A Twentieth-Century Agency in a Postmodern World, by Theodore W. Ruger
  • 5. 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 Accountability; Introduction, by Christopher Robertson; 6. Global Trends Toward Transparency in Participant-Level Clinical Trials Data, by Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer; 7. Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties, by Genevieve Pham-Kanter; 8. The Crime of Being in Charge: Executive Culpability and Collateral Consequences, by Katrice Bridges Copeland
  • 9. 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 Limits; Introduction, by Glenn Cohen; 10. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, by Aaron S. Kesselheim and Michelle M. Mello; 11. The FDCA as the Test for Truth of Promotional Claims, by Christopher Robertson
  • 12. 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 Uncertainty; Introduction, by W. Nicholson Price II; 13. Speed Versus Safety in Drug Development, by R. Alta Charo; 14. Overcoming "Premarket Syndrome": Promoting Better Postmarket Surveillance in an Evolving Drug Development Context, by Shannon Gibson and Trudo Lemmens; 15. FDA's Public Health Imperative: An Increased Role for Active Postmarket Analysis, by Efthimios Parasidis
  • Part 5. Old and New Issues in Drug RegulationIntroduction, by Alta Charo; 16. The Drug Efficacy Study and Its Manifold Legacies, by Daniel Carpenter, Jeremy Greene, and Susan Moffitt; 17. Drug Safety Communication: The Evolving Environment, by Geoffrey Levitt; 18. Innovation Policy Failures in the Manufacturing of Drugs, by W. Nicholson Price II; Part 6. Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars; Introduction, by Benjamin N. Roin; 19. From "Recycled Molecule" to Orphan Drug: Lessons from Makena, by Kate Greenwood
  • 20. FDA, Negotiated Rule Making, and Generics: A Proposal, by Marie Boyd
Dimensions
unknown
Extent
1 online resource (568 p.)
Form of item
online
Isbn
9780231540070
Media category
computer
Media type code
c
Specific material designation
remote
System control number
  • (CKB)3710000000464019
  • (EBL)2147427
  • (SSID)ssj0001530048
  • (PQKBManifestationID)12572612
  • (PQKBTitleCode)TC0001530048
  • (PQKBWorkID)11536306
  • (PQKB)10878234
  • (StDuBDS)EDZ0001188775
  • (MiAaPQ)EBC2147427
  • (EXLCZ)993710000000464019
Label
FDA in the twenty-first century : the challenges of regulating drugs and new technologies, edited by Holly Fernandez Lynch and I. Glenn Cohen
Publication
Copyright
Note
Description based upon print version of record
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier category code
cr
Content category
text
Content type code
txt
Contents
  • Table of Contents; Acknowledgments; Introduction, by Holly Fernandez Lynch and I. Glenn Cohen; 1. Historical Themes and Developments at FDA Over the Past Fifty Years, by Peter Barton Hutt; Part 1. FDA in a Changing World; Introduction, by Holly Fernandez Lynch; 2. A Global and Innovative Regulatory Environment for the U.S. FDA, by Howard Sklamberg and Jennifer Devine; 3. FDA and the Rise of the Empowered Patient, by Lewis A. Grossman; 4. After the FDA: A Twentieth-Century Agency in a Postmodern World, by Theodore W. Ruger
  • 5. 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 Accountability; Introduction, by Christopher Robertson; 6. Global Trends Toward Transparency in Participant-Level Clinical Trials Data, by Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer; 7. Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties, by Genevieve Pham-Kanter; 8. The Crime of Being in Charge: Executive Culpability and Collateral Consequences, by Katrice Bridges Copeland
  • 9. 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 Limits; Introduction, by Glenn Cohen; 10. Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection, by Aaron S. Kesselheim and Michelle M. Mello; 11. The FDCA as the Test for Truth of Promotional Claims, by Christopher Robertson
  • 12. 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 Uncertainty; Introduction, by W. Nicholson Price II; 13. Speed Versus Safety in Drug Development, by R. Alta Charo; 14. Overcoming "Premarket Syndrome": Promoting Better Postmarket Surveillance in an Evolving Drug Development Context, by Shannon Gibson and Trudo Lemmens; 15. FDA's Public Health Imperative: An Increased Role for Active Postmarket Analysis, by Efthimios Parasidis
  • Part 5. Old and New Issues in Drug RegulationIntroduction, by Alta Charo; 16. The Drug Efficacy Study and Its Manifold Legacies, by Daniel Carpenter, Jeremy Greene, and Susan Moffitt; 17. Drug Safety Communication: The Evolving Environment, by Geoffrey Levitt; 18. Innovation Policy Failures in the Manufacturing of Drugs, by W. Nicholson Price II; Part 6. Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars; Introduction, by Benjamin N. Roin; 19. From "Recycled Molecule" to Orphan Drug: Lessons from Makena, by Kate Greenwood
  • 20. FDA, Negotiated Rule Making, and Generics: A Proposal, by Marie Boyd
Dimensions
unknown
Extent
1 online resource (568 p.)
Form of item
online
Isbn
9780231540070
Media category
computer
Media type code
c
Specific material designation
remote
System control number
  • (CKB)3710000000464019
  • (EBL)2147427
  • (SSID)ssj0001530048
  • (PQKBManifestationID)12572612
  • (PQKBTitleCode)TC0001530048
  • (PQKBWorkID)11536306
  • (PQKB)10878234
  • (StDuBDS)EDZ0001188775
  • (MiAaPQ)EBC2147427
  • (EXLCZ)993710000000464019

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