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Articles (19)

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1-10 of 19 results for Prescription Drug User Fee Act

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Select article: The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines

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First published 2001-1

The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines

Janice M. Reichert, Jennifer Chee, Claire S. Kotzampaltiris

Therapeutic Innovation & Regulatory Science

Select article: The New Drug Approvals of 1999,2000,and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992

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First published 2003-10

The New Drug Approvals of 1999,2000,and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992

Kenneth I. Kaitin, Catherine Cairns

Therapeutic Innovation & Regulatory Science

Select article: The Prescription Drug User Fee Act: Cause for Concern?

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Research article

First published 2018-4

The Prescription Drug User Fee Act: Cause for Concern?

Michael Gabay

Hospital Pharmacy

Select article: Pharmacoepidemiology in Safety Evaluations of Newly Approved Medications

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First published 2004-1

Pharmacoepidemiology in Safety Evaluations of Newly Approved Medications

Elane M. Gutterman

Therapeutic Innovation & Regulatory Science

Select article: The December Effect in FDA Drug Approvals: Assessing the Submissions Echo Hypothesis

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Research article

First published 2007-9

The December Effect in FDA Drug Approvals: Assessing the Submissions Echo Hypothesis

James B. Graham, Ernst R. Berndt

Therapeutic Innovation & Regulatory Science

Select article: Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan

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First published 2008-08

Prescription Drug User Fee Act (PDUFA) IV Drug Safety Five-Year Plan

Biotechnology Law Report

Select article: Measuring the Pace of New Drug Development in the User Fee ERA

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First published 2000-7

Measuring the Pace of New Drug Development in the User Fee ERA

Kenneth I. Kaitin, Joseph A. DiMasi

Therapeutic Innovation & Regulatory Science

Select article: Recent Developments in Health Law: FDA and Drug Safety: New Tufts Study Challenges Critics of the Prescription Drug User Fee Act

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First published 2006-3

Recent Developments in Health Law: FDA and Drug Safety: New Tufts Study Challenges Critics of the Prescription Drug User Fee Act

Rochelle Lee

The Journal of Law,Medicine & Ethics

Select article: Breakthrough Therapy Designation

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First published 2015-3

Breakthrough Therapy Designation

Arpita Shah

Therapeutic Innovation & Regulatory Science

Select article: The New Drug Approvals of 1996,1997,and 1998: Drug Development Trends in the User Fee Era *

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First published 2000-1

The New Drug Approvals of 1996,1997,and 1998: Drug Development Trends in the User Fee Era *

Kenneth I. Kaitin, Elaine M. Healy

Therapeutic Innovation & Regulatory Science

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