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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


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


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


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


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