- Title Pages
- Dedication
- Acknowledgments
- Introduction
-
Chapter One Historical Themes and Developments at FDA Over the Past Fifty Years - Introduction
-
Chapter Two A Global and Innovative Regulatory Environment for the U.S. FDA -
Chapter Three FDA and the Rise of the Empowered Patient -
Chapter Four After the FDA -
Chapter Five The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007 - Introduction
-
Chapter Six Global Trends Toward Transparency in Participant-Level Clinical Trials Data -
Chapter Seven Conflicts of Interest in FDA Advisory Committees -
Chapter Eight The Crime of Being in Charge -
Chapter Nine Recalibrating Enforcement in the Biomedical Industry - Introduction
-
Chapter Ten Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection -
Chapter Eleven The FDCA as the Test for Truth of Promotional Claims -
Chapter Twelve Why FDA’s Ban on Off-Label Promotion Violates the First Amendment - Introduction
-
Chapter Thirteen Speed Versus Safety in Drug Development -
Chapter Fourteen Overcoming “Premarket Syndrome” -
Chapter Fifteen FDA’s Public Health Imperative - Introduction
-
Chapter Sixteen The Drug Efficacy Study and Its Manifold Legacies -
Chapter Seventeen Drug Safety Communication -
Chapter Eighteen Innovation Policy Failures in the Manufacturing of Drugs - Introduction
-
Chapter Nineteen From “Recycled Molecule” to Orphan Drug -
Chapter Twenty FDA, Negotiated Rulemaking, and Generics -
Chapter Twenty-One The “Follow-On” Challenge -
Chapter Twenty-Two FDA Regulation of Biosimilars - Introduction
-
Chapter Twenty-Three Analog Agency in a Digital World -
Chapter Twenty-Four Twenty-First-Century Technology with Twentieth-Century Baggage -
Chapter Twenty-Five Device-ive Maneuvers -
Chapter Twenty-Six A New Regulatory Function for E-Prescriptions -
Chapter Twenty-Seven Race and the FDA - Contributors
- Index
FDA’s Public Health Imperative
FDA’s Public Health Imperative
An Increased Role for Active Postmarket Analysis
- Chapter:
- (p.286) Chapter Fifteen FDA’s Public Health Imperative
- Source:
- FDA in the Twenty-First Century
- Author(s):
Efthimios Parasidis
- Publisher:
- Columbia University Press
This chapter focuses on current and emerging issues related to post-market analysis of medical products. It argues that the future of the FDA as a public health agency is largely dependent on how well the agency leverages its mandate and resources to address the limitations of pre-market review and expand the instances in which post-market analysis is required.
Keywords: FDA, Post-market surveillance, Sentinel System, Public Health, Big Data
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- Title Pages
- Dedication
- Acknowledgments
- Introduction
-
Chapter One Historical Themes and Developments at FDA Over the Past Fifty Years - Introduction
-
Chapter Two A Global and Innovative Regulatory Environment for the U.S. FDA -
Chapter Three FDA and the Rise of the Empowered Patient -
Chapter Four After the FDA -
Chapter Five The Future of Prospective Medicine Under the Food and Drug Administration Amendments Act of 2007 - Introduction
-
Chapter Six Global Trends Toward Transparency in Participant-Level Clinical Trials Data -
Chapter Seven Conflicts of Interest in FDA Advisory Committees -
Chapter Eight The Crime of Being in Charge -
Chapter Nine Recalibrating Enforcement in the Biomedical Industry - Introduction
-
Chapter Ten Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection -
Chapter Eleven The FDCA as the Test for Truth of Promotional Claims -
Chapter Twelve Why FDA’s Ban on Off-Label Promotion Violates the First Amendment - Introduction
-
Chapter Thirteen Speed Versus Safety in Drug Development -
Chapter Fourteen Overcoming “Premarket Syndrome” -
Chapter Fifteen FDA’s Public Health Imperative - Introduction
-
Chapter Sixteen The Drug Efficacy Study and Its Manifold Legacies -
Chapter Seventeen Drug Safety Communication -
Chapter Eighteen Innovation Policy Failures in the Manufacturing of Drugs - Introduction
-
Chapter Nineteen From “Recycled Molecule” to Orphan Drug -
Chapter Twenty FDA, Negotiated Rulemaking, and Generics -
Chapter Twenty-One The “Follow-On” Challenge -
Chapter Twenty-Two FDA Regulation of Biosimilars - Introduction
-
Chapter Twenty-Three Analog Agency in a Digital World -
Chapter Twenty-Four Twenty-First-Century Technology with Twentieth-Century Baggage -
Chapter Twenty-Five Device-ive Maneuvers -
Chapter Twenty-Six A New Regulatory Function for E-Prescriptions -
Chapter Twenty-Seven Race and the FDA - Contributors
- Index
