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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


The Role of the Political Branches: Negotiating Federalism

Erin Ryan

in Federalism and the Tug of War Within

Published in print:
2011
Published Online:
January 2012
ISBN:
9780199737987
eISBN:
9780199918652
Item type:
chapter
Publisher:
Oxford University Press
DOI:
10.1093/acprof:oso/9780199737987.003.0008
Subject:
Law, Constitutional and Administrative Law

Chapter Eight summarizes the federalism safeguards debate, considers the role of negotiated governance, and highlights potential contributions from the academic negotiation literature. Most ... More


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