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Regulation of Drugs and Health Care Products

Robert I. Field

in Health Care Regulation in America: Complexity, Confrontation, and Compromise

Published in print:
2006
Published Online:
September 2009
ISBN:
9780195159684
eISBN:
9780199864423
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195159684.003.0005
Subject:
Public Health and Epidemiology, Public Health, Epidemiology

This chapter reviews the regulation of drugs and products for safety and efficacy. It begins with a history of drug regulation, covering public health crises that engendered major expansions in 1906, ... More


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

Holly Fernandez Lynch and I. Glenn Cohen (eds)

Published in print:
2015
Published Online:
May 2016
ISBN:
9780231171182
eISBN:
9780231540070
Item type:
book
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231171182.001.0001
Subject:
Law, Medical Law

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 ... 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


How the Government Created the Pharmaceutical Industry

Robert I. Field

in Mother of Invention: How the Government Created "Free-Market" Health Care

Published in print:
2013
Published Online:
January 2014
ISBN:
9780199746750
eISBN:
9780199354528
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199746750.003.0003
Subject:
Public Health and Epidemiology, Public Health

The pharmaceutical industry, perennially one of the most profitable,requires a steady flow of biomedical research to develop new products. However, investment in basic scienceis difficult for private ... More


FDA and the Rise of the Empowered Patient

Lewis A. Grossman

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/9780231171182.003.0005
Subject:
Law, Medical Law

Although as recently as the 1970s patients had virtually no voice in FDA’s regulation of drugs, today patient advocates regularly use various administrative mechanisms to influence and even directly ... More


The Use of Evidence: Federal Regulation of Prescription Drugs and Medical Devices

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/9780199968565.003.0002
Subject:
Public Health and Epidemiology, Public Health

The U.S. Food and Drug Administration is statutorily responsible for ensuring that prescription drugs and medical devices meet evidential standards for safety and efficacy before they are approved ... More


The More Things Change: A Historical Perspective on the Debate over Vitamin Advertising in the United States

Rima D. Apple

in Silent Victories: The History and Practice of Public Health in Twentieth Century America

Published in print:
2006
Published Online:
September 2009
ISBN:
9780195150698
eISBN:
9780199865185
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195150698.003.09
Subject:
Public Health and Epidemiology, Public Health, Epidemiology

Vitamin supplements have been popular from the time the micronutrients were discovered in the early 20th century. Popular news media and advertisements promoted vitamins as crucial for two critical ... More


Networks of Calibration

S. Scott Graham

in The Politics of Pain Medicine: A Rhetorical-Ontological Inquiry

Published in print:
2015
Published Online:
May 2016
ISBN:
9780226264059
eISBN:
9780226264196
Item type:
chapter
Publisher:
University of Chicago Press
DOI:
10.7208/chicago/9780226264196.003.0007
Subject:
History, History of Science, Technology, and Medicine

This chapter investigates the networks of calibration that surround the Food and Drug Administration as an institution of rarefaction. The chapter explores how different professional organizations, ... More


Advances in Food Safety to Prevent Foodborne Diseases in the United States

Robert V. Tauxe and Emilio J. Esteban

in Silent Victories: The History and Practice of Public Health in Twentieth Century America

Published in print:
2006
Published Online:
September 2009
ISBN:
9780195150698
eISBN:
9780199865185
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195150698.003.02
Subject:
Public Health and Epidemiology, Public Health, Epidemiology

In the United States, the current food supply is broader and far safer than it was 100 years ago. At the start of the 20th century, contaminated foods frequently caused botulism, typhoid fever, ... More


The Government and the Private Market in Health Care

Robert I. Field

in Mother of Invention: How the Government Created "Free-Market" Health Care

Published in print:
2013
Published Online:
January 2014
ISBN:
9780199746750
eISBN:
9780199354528
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199746750.003.0002
Subject:
Public Health and Epidemiology, Public Health

The American health care system, which appears on its surface as a predominantly private endeavour, actually rests on a foundation of government support. Itreflects a huge public-private partnership ... More


Introduction

David B. Resnik

in Playing Politics with Science: Balancing Scientific Independence and Government Oversight

Published in print:
2009
Published Online:
January 2009
ISBN:
9780195375893
eISBN:
9780199866632
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195375893.003.0001
Subject:
Philosophy, Moral Philosophy

This chapter provides an introduction to the primary topics addressed in the book: scientific autonomy/independence and government oversight. It gives an overview of the relationship between science ... More


The Public Interest in Regulatory Practice: the USA

Mike Feintuck

in ‘The Public Interest’ in Regulation

Published in print:
2004
Published Online:
March 2012
ISBN:
9780199269020
eISBN:
9780191699320
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199269020.003.0004
Subject:
Law, Constitutional and Administrative Law

The federal and fiercely republican context in which regulation of private activity takes place in the United States has led to a very different administrative tradition from that of the United ... More


Elixir Sulfanilamide

Joshua M. Sharfstein

in The Public Health Crisis Survival Guide: Leadership and Management in Trying Times

Published in print:
2018
Published Online:
June 2018
ISBN:
9780190697211
eISBN:
9780190697242
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/oso/9780190697211.003.0002
Subject:
Public Health and Epidemiology, Public Health

In the fall of 1937, patients began to die soon after consuming a new therapy called the Elixir Sulfanilamide. In response, the fledgling agency known as the U.S. Food and Drug Administration (FDA) ... More


Public Interest Lost

in The People's Agents and the Battle to Protect the American Public: Special Interests, Government, and Threats to Health, Safety, and the Environment

Published in print:
2010
Published Online:
March 2013
ISBN:
9780226772028
eISBN:
9780226772042
Item type:
chapter
Publisher:
University of Chicago Press
DOI:
10.7208/chicago/9780226772042.003.0001
Subject:
Law, Environmental and Energy Law

The fundamental principle—that government has a vital role to play in protecting people from harm—could lead to endless arguments in the arena of traditional social welfare programs over exactly when ... More


Protecting food, water, and ambient air

Craig W. Hedberg, Jeffrey B. Bender, and Donald Vesley

in Terrorism and Public Health: A balanced approach to strengthening systems and protecting people

Published in print:
2007
Published Online:
September 2009
ISBN:
9780195325256
eISBN:
9780199864409
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780195325256.003.0016
Subject:
Public Health and Epidemiology, Public Health, Epidemiology

This chapter describes protecting food, water, and ambient air. It discusses progress in developing and implementing environmental health measures during the 20th century. It describes challenges ... More


Jif: “But Is It Still Peanut Butter?”

Jon Krampner

in Creamy and Crunchy: An Informal History of Peanut Butter, the All-American Food

Published in print:
2014
Published Online:
November 2015
ISBN:
9780231162333
eISBN:
9780231530934
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231162333.003.0008
Subject:
History, Social History

This chapter charts the history of the Jif brand of peanut butter. In 1946 William T. Young, who served stateside as an officer in the ordnance branch of the U.S. Army during World War II, started ... More


How My Cells Became Drugs

Sheldon Krimsky

in Stem Cell Dialogues: A Philosophical and Scientific Inquiry Into Medical Frontiers

Published in print:
2015
Published Online:
November 2015
ISBN:
9780231167482
eISBN:
9780231539401
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231167482.003.0024
Subject:
Biology, Bioethics

This dialogue is a fictional account of the legal arguments before the U.S. District Court, District of Columbia, regarding the case United States v. Regenerative Sciences LLC. A company named ... More


Food Cooperatives, 1960s–1990s

Anne Meis Knupfer

in Food Co-ops in America: Communities, Consumption, and Economic Democracy

Published in print:
2013
Published Online:
August 2016
ISBN:
9780801451140
eISBN:
9780801467714
Item type:
chapter
Publisher:
Cornell University Press
DOI:
10.7591/cornell/9780801451140.003.0008
Subject:
History, American History: 20th Century

This chapter turns to food cooperatives established during the 1960s and 1970s. It discusses food co-ops as one of the many social movements of the time, and the challenges the co-ops faced during ... More


BiDil and Racialized Medicine

Jonathan Kahn

in Race and the Genetic Revolution: Science, Myth, and Culture

Published in print:
2011
Published Online:
November 2015
ISBN:
9780231156974
eISBN:
9780231527699
Item type:
chapter
Publisher:
Columbia University Press
DOI:
10.7312/columbia/9780231156974.003.0007
Subject:
Sociology, Race and Ethnicity

This chapter discusses the use of racialized medicine, specifically BiDil, and the concerns that emerge over the dangers of reifying race in a manner that could lead to new forms of discrimination. ... More


Thalidomide

Joshua M. Sharfstein

in The Public Health Crisis Survival Guide: Leadership and Management in Trying Times

Published in print:
2018
Published Online:
June 2018
ISBN:
9780190697211
eISBN:
9780190697242
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/oso/9780190697211.003.0003
Subject:
Public Health and Epidemiology, Public Health

In 1962, the United States found itself transfixed by a crisis involving the medication thalidomide. Marketed widely in Europe for a variety of ailments, including nausea during pregnancy, ... More


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