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Research article

First published 2019-1

Common Filing Deficiencies in Abbreviated New Drug Applications Containing Clinical Endpoint Studies

Lewis J. Fermaglich, Ru Chen, Carol Y. Kim [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2005-7

Teva v Pfizer: Creating an Uncertain Future for Generics Companies by De-Modernising the Medicare Modernization Act

Frederick H. Rein, Dominique T. Hussey

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 2019-9

Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality Metrics

Jason Woo, Jingyu (Julia) Luan, Zili Li [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2006-7

Drug Master file Review Issues at the Office of Generic Drugs

Paul Schwartz

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 2004-4

Pharmaceutical Pricing and Hatch–Waxman Reform: The Right Prescription

Allison K. Young, Meredyth Smith Andrus

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 2007-7

US FDA Question-Based Review for Generic Drugs: A New Pharmaceutical Quality Assessment System

Lawrence X. Yu, Andre Raw, Robert Lionberger [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 2017-12

Generic Drug User Fee Act II: The positive features for generic drug industry

Jignesh Prajapati, Darshit Patel

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 2017-7

The Landscape of Contract Manufacturing of Sterile Injectable Drugs

William Liu, Marta E. Wosinska

Therapeutic Innovation & Regulatory Science

Free access

Editorial

First published 2011-2

The United States Food and Drugs Administration Approves a Generic Enoxaparin

Frederick A. Ofosu

Clinical and Applied Thrombosis/Hemostasis

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Research article

First published 2009-8

Presence of Indian Pharmaceutical Industries in US Market: An Empirical Analysis

Jena Deepak Kumar, Vishwajeet Mohan, Padmanabhuni Venkata Appaji [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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