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Drug Safety Communication: The Evolving Environment

Geoffrey Levitt

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/9780231171182.003.0023
Subject:
Law, Medical Law

Over the last decade, control over communications about the safety of medicines has shifted away from drug sponsors and regulators to a broader set of stakeholders including payors, academic ... 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


Bayesian Methods in Pharmacovigilance *

David Madigan, Patrick Ryan, Shawn Simpson, and Ivan Zorych

in Bayesian Statistics 9

Published in print:
2011
Published Online:
January 2012
ISBN:
9780199694587
eISBN:
9780191731921
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199694587.003.0014
Subject:
Mathematics, Probability / Statistics

Regulators such as the U.S. Food and Drug Administration have elaborate, multi‐year processes for approving new drugs as safe and effective. Nonetheless, in recent years, several approved drugs have ... More


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