- 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
Analog Agency in a Digital World
Analog Agency in a Digital World
- Chapter:
- (p.438) Chapter Twenty-Three Analog Agency in a Digital World
- Source:
- FDA in the Twenty-First Century
- Author(s):
Nathan Cortez
- Publisher:
- Columbia University Press
This chapter examines how the FDA has regulated computer hardware and software the last 40 years, finding several recurrent problems that neither the agency nor Congress has effectively addressed. The FDA needs updated statutory authority and increased in-house resources to modernize its approach to computerized devices, which now comprise over half of all medical devices on the market.
Keywords: FDA, Devices, Software, Computers, Digital, mobile
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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
