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Childhood ADHD: Biological Reality or Social Construction, with Policy Implications

Stephen P. Hinshaw

in Raising Children: Emerging Needs, Modern Risks, and Social Responses

Published in print:
2008
Published Online:
January 2009
ISBN:
9780195310122
eISBN:
9780199865284
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195310122.003.0008
Subject:
Social Work, Social Policy, Children and Families

One of the greatest challenges that parents confront in raising children involves monitoring their health and managing to obtain the proper treatment when needed. Yet many parents are unable to ... More


From Visible Harm to Relative Risk: Centralization and Fragmentation of Pharmacovigilance

Arthur Daemmrich and Jeremy Greene

in The Fragmentation of U.S. Health Care: Causes and Solutions

Published in print:
2010
Published Online:
May 2010
ISBN:
9780195390131
eISBN:
9780199775934
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195390131.003.013
Subject:
Law, Medical Law

Adverse drug reactions pose distinct but potentially catastrophic risks to patients, doctors, pharmaceutical firms, and regulators. Between the early 1960s and the present, national systems were ... More


Innovation Markets: Saving Lives and Money in the Pharmaceutical Industry

Michael A. Carrier

in Innovation for the 21st Century: Harnessing the Power of Intellectual Property and Antitrust Law

Published in print:
2009
Published Online:
May 2009
ISBN:
9780195342581
eISBN:
9780199867035
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195342581.003.0013
Subject:
Law, Intellectual Property, IT, and Media Law

This chapter begins by defining innovation markets, which are markets for research and development (R&D). It then sets forth the critiques that have been leveled against the markets. It proposes a ... More


PostMarket Surveillance of Medical Products in the United States

Paul J. Seligman, Thomas P. Gross, M. Miles Braun, and Janet B. Arrowsmith

in Principles & Practice of Public Health Surveillance

Published in print:
2010
Published Online:
September 2010
ISBN:
9780195372922
eISBN:
9780199866090
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195372922.003.0016
Subject:
Public Health and Epidemiology, Public Health

This chapter describes the application of specific principles to the practice of postmarket monitoring pharmaceutical products and medical devices. The purpose of postmarket surveillance is the ... More


Historical Themes and Developments at FDA Over the Past Fifty Years

Peter Barton Hutt

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0002
Subject:
Law, Medical Law

This chapter provides an overview of FDA’s history as a regulatory institution that now touches products comprising twenty-five cents out of every dollar spent by U.S. consumers, outlining agency ... More


After the FDA: A Twentieth-Century Agency in a Postmodern World

Theodore W. Ruger

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0006
Subject:
Law, Medical Law

The FDA over the past century has achieved high levels of regulatory prestige by enforcing statutory standards of safety and efficacy with relatively little regulation of the end-stage use, or the ... More


Conflicts of Interest in FDA Advisory Committees: The Paradox of Multiple Financial Ties

Genevieve Pham-Kanter

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0010
Subject:
Law, Medical Law

This chapter summarizes findings from an analysis of financial ties of FDA advisory committee members during the 15-year period covering 1997-2011. Focusing on a facet of conflicts of interest that ... More


Prospects for Regulation of Off-Label Drug Promotion in an Era of Expanding Commercial Speech Protection

Aaron S. Kesselheim and Michelle M. Mello

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0014
Subject:
Law, Medical Law

The FDA prevents prescription drug manufacturers from directly promoting their products for uses that the FDA has not validated (“off-label” uses), but in the recent case of United States v. Caronia, ... More


FDA’s Public Health Imperative: An Increased Role for Active Postmarket Analysis

Efthimios Parasidis

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0020
Subject:
Law, Medical Law

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 ... More


The Drug Efficacy Study and Its Manifold Legacies

Daniel Carpenter, Jeremy Greene, and Susan Moffitt

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0022
Subject:
Law, Medical Law

The Drug Efficacy Study Initiative decisively reshaped modern drug regulation. Our purpose in reviewing the development of the Drug Efficacy Study and its implementation is threefold: to demonstrate ... More


Innovation Policy Failures in the Manufacturing of Drugs

W. Nicholson Price

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0024
Subject:
Law, Medical Law

Drug manufacturing today is both high cost and poor quality, due largely to stagnant technological development. Improving innovation incentives and decreasing regulatory hurdles could lead to ... More


FDA, Negotiated Rulemaking, and Generics: A Proposal

Marie Boyd

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0027
Subject:
Law, Medical Law

Recent U.S. Supreme Court holdings suggest that while the manufacturer of a brand-name drug is always responsible for its label’s content, this is not the case for generic drugs. In addition, these ... More


FDA Regulation of Biosimilars

Henry Grabowski and Erika Lietzan

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0029
Subject:
Law, Medical Law

The FDA requirements for products to be approved as a biosimilar to a reference biological drug product will have a profound impact on market entry, competition and cost savings to consumers.


Analog Agency in a Digital World

Nathan Cortez

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0031
Subject:
Law, Medical Law

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. ... More


Race and the FDA

Jonathan Kahn

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

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.003.0035
Subject:
Law, Medical Law

The FDA has played a prominent role in efforts to harmonize international regulatory schemes for pharmaceutical review and approval, including the promulgation of guidelines on the use of racial and ... More


The Subversion of Evidence: The Rosiglitazone Story

Carol M. Ashton and Nelda P. Wray

in Comparative Effectiveness Research: Evidence, Medicine, and Policy

Published in print:
2013
Published Online:
September 2013
ISBN:
9780199968565
eISBN:
9780199346080
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199968565.003.0003
Subject:
Public Health and Epidemiology, Public Health

The principles of design, conduct, analysis and reporting of clinical trials, including trials conducted for regulatory purposes, are sufficiently advanced that drugs and other therapeutic ... More


Why Regulate Medicines?

Michael Kinch

in Prescription for Change: The Looming Crisis in Drug Development

Published in print:
2016
Published Online:
May 2017
ISBN:
9781469630625
eISBN:
9781469630649
Item type:
chapter
Publisher:
University of North Carolina Press
DOI:
10.5149/northcarolina/9781469630625.003.0002
Subject:
Business and Management, Innovation

The prehistory of the modern pharmaceutical era is recounted, with emphasis upon the products, including the emergence of snake oil remedies, tapeworm diets and dangerous yet contemporary quack ... More


Triumph and Tragedy

Michael Kinch

in Prescription for Change: The Looming Crisis in Drug Development

Published in print:
2016
Published Online:
May 2017
ISBN:
9781469630625
eISBN:
9781469630649
Item type:
chapter
Publisher:
University of North Carolina Press
DOI:
10.5149/northcarolina/9781469630625.003.0005
Subject:
Business and Management, Innovation

Industry growth mirrored innovation taking place in all aspects of understanding disease and ways to ameliorate it. All of this knowledge was needed to tackle the most deadly disease of modern times, ... More


Bridging the Valley

Michael Kinch

in Prescription for Change: The Looming Crisis in Drug Development

Published in print:
2016
Published Online:
May 2017
ISBN:
9781469630625
eISBN:
9781469630649
Item type:
chapter
Publisher:
University of North Carolina Press
DOI:
10.5149/northcarolina/9781469630625.003.0013
Subject:
Business and Management, Innovation

The withdrawal of large company support for early stage research, combined with shrinking Federal expenditures, has created a “Valley of Death” in drug discovery that creates both pressing challenges ... More


Capitalizing [on] Race in Drug Development

Sheldon Krimsky

in Race in a Bottle: The Story of BiDil and Racialized Medicine in a Post-Genomic Age

Published in print:
2014
Published Online:
November 2015
ISBN:
9780231162999
eISBN:
9780231531276
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231162999.003.0004
Subject:
Public Health and Epidemiology, Public Health

This chapter provides a close reading of the FDA hearing that approved the race-specific indication for BiDil, in which the racial frame played a critical role in shaping how the committee reviewed ... More


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