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Articles (1461)

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1-10 of 1461 results for New Drug Applications

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Select article: The 505(b)(2) New Drug Application

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Other

First published 2007-5

The 505(b)(2) New Drug Application

J. Christopher Prue, Arthur J. Mayorga

Therapeutic Innovation & Regulatory Science

Select article: Transaction Cost Analysis of the New Drug Application Process

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Research article

First published 2014-5

Transaction Cost Analysis of the New Drug Application Process

Shota Hamada, Akiko Shibata, Hisashi Urushihara [...]

Therapeutic Innovation & Regulatory Science

Select article: ‘Old Drugs for New Applications’ : Can Orthopedic Research Benefit from This Strategy?

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Review article

First published 2011-8

‘Old Drugs for New Applications’ : Can Orthopedic Research Benefit from This Strategy?

Xiaohua Pan, Wenxiang Cheng, Jiali Wang [...]

Therapeutic Advances in Musculoskeletal Disease

Select article: Clarifying the Discussion Points in New Drug Application Reviews for Approval in Japan by a Government Advisory Council

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Research article

First published 2017-7

Clarifying the Discussion Points in New Drug Application Reviews for Approval in Japan by a Government Advisory Council

Yasuyuki Hattori, Hideki Hanaoka, Yoshiaki Uyama

Therapeutic Innovation & Regulatory Science

Select article: Strategic Shift of Statistical Review on Data Quality Assessment for New Drug Applications in China

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Research article

First published 2019-3

Strategic Shift of Statistical Review on Data Quality Assessment for New Drug Applications in China

Jun Wang, Gang Wang, Min Li [...]

Therapeutic Innovation & Regulatory Science

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

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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

Select article: The Review of New Drug Applications in Japan: The Decline in Approval Times after the Introduction of an Internalized Review System

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First published 2005-7

The Review of New Drug Applications in Japan: The Decline in Approval Times after the Introduction of an Internalized Review System

Shunsuke Ono, Chisato Yoshioka, Orie Asaka [...]

Therapeutic Innovation & Regulatory Science

Select article: Remote Data Entry and the Electronic New Drug Application: An Integrated Approach to Acquire,Analyze,and Review New Drug Data

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First published 1987-1

Remote Data Entry and the Electronic New Drug Application: An Integrated Approach to Acquire,Analyze,and Review New Drug Data

Joel Morganroth

Therapeutic Innovation & Regulatory Science

Select article: An Overview of How the Food and Drug Administration Regulates New Drug Development in the United States

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Research article

First published 1996-7

An Overview of How the Food and Drug Administration Regulates New Drug Development in the United States

Stan Stringer

Therapeutic Innovation & Regulatory Science

Select article: An Overview of the Regulatory Approval Process in Drug Development

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First published 1998-10

An Overview of the Regulatory Approval Process in Drug Development

Shein-Chung Chow, Annpey Pong

Therapeutic Innovation & Regulatory Science

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