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FDA in the Twenty-First Century
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FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies

Holly Fernandez Lynch and I. Glenn Cohen

Abstract

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 ... More

Keywords: Pharmaceuticals, Consumer protection, Regulation, Food and Drug Administration, Drug testing, Drug marketing

Bibliographic Information

Print publication date: 2015 Print ISBN-13: 9780231171182
Published to Columbia Scholarship Online: May 2016 DOI:10.7312/columbia/9780231171182.001.0001

Authors

Affiliations are at time of print publication.

Holly Fernandez Lynch, editor
Harvard Law School

I. Glenn Cohen, editor

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Contents

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Introduction

Holly Fernandez Lynch and I. Glenn Cohen

Part One FDA in a Changing World

Introduction

Holly Fernandez Lynch

Chapter Four After the FDA

Theodore W. Ruger

Part Two Preserving Public Trust and Demanding Accountability

Introduction

Christopher Robertson

Chapter Six Global Trends Toward Transparency in Participant-Level Clinical Trials Data

Alla Digilova, Rebecca Li, Mark Barnes, and Barbara Bierer

Part Three Protecting the Public Within Constitutional Limits

Introduction

I. Glenn Cohen

Part Four Timing Is Everything: Balancing Access and Uncertainty

Introduction

W. Nicholson Price II

Chapter Fourteen Overcoming “Premarket Syndrome”

Shannon Gibson and Trudo Lemmens

Part Five Old and New Issues in Drug Regulation

Introduction

R. Alta Charo

Chapter Sixteen The Drug Efficacy Study and Its Manifold Legacies

Daniel Carpenter, Jeremy Greene, and Susan Moffitt

Part Six Regulatory Exclusivities and the Regulation of Generic Drugs and Biosimilars

Introduction

Benjamin N. Roin

Chapter Twenty-Two FDA Regulation of Biosimilars

Henry Grabowski and Erika Lietzan

Part Seven New Wine in Old Bottles: FDA’s Role in Regulating New Technologies

Introduction

Frances H. Miller

Chapter Twenty-Five Device-ive Maneuvers

Elizabeth R. Pike and Kayte Spector-Bagdady

Chapter Twenty-Six A New Regulatory Function for E-Prescriptions

Andrew English, David Rosenberg, and Huaou Yan

End Matter