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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 1993-4

The Food and Drug Administration Office of Compliance's Role in the Preapproval Process

Paul Vogel

Therapeutic Innovation & Regulatory Science

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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 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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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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Other

First published 2004-1

Secrets of Successful Patent (Non)Litigation

Thomas M. Saunders, Brian L. Michaelis

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

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News

First published 1997-11

{BLR 2489}Andas - Ferring - Infertility - Serono

Biotechnology Law Report

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Research article

First published 2012-08

AstraZeneca v. Apotex : ANDA Suit for Unpatented Uses Dismissed

By Harold C. Wegner

Biotechnology Law Report

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Research article

First published 2011-1

How suitable are the suitability petition and 505(b)(2)?

Nirav Chokshi, Bhaumik Modi

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

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Other

First published 2000-2

“Dime con Quien Andas”: Notions of Chicano and Mexican American Families

Josephine Méndez-Negrete

Families in Society: The Journal of Contemporary Social Services

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