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Articles (78)

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1-10 of 78 results for New Drug Application (NDA)

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Select article: What is the Future of the Canda at FDA?

Retricted access

Research article

First published 1994-4

What is the Future of the Canda at FDA?

Robert A. Bell

Therapeutic Innovation & Regulatory Science

Select article: The Value of Candas in Drug Development

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Research article

First published 1996-1

The Value of Candas in Drug Development

Stephanie Kirk

Therapeutic Innovation & Regulatory Science

Select article: Are Initiatives to Speed the New Drug Approval Process Working?

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Research article

First published 1992-7

Are Initiatives to Speed the New Drug Approval Process Working?

Kenneth I. Kaitin, Helen L. Walsh

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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Other

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: An Overview of the Regulatory Approval Process in Drug Development

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Other

First published 1998-10

An Overview of the Regulatory Approval Process in Drug Development

Shein-Chung Chow, Annpey Pong

Therapeutic Innovation & Regulatory Science

Select article: Cell Therapy Regulation in Taiwan

Free access

Review article

First published 2017-3

Cell Therapy Regulation in Taiwan

Yuan-Chuan Chen, Hwei-Fang Cheng, Ming-Kung Yeh

Cell Transplantation

Select article: Six Enduring Principles for Preparing NDAS

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Other

First published 2000-7

Six Enduring Principles for Preparing NDAS

Michael J. Umen

Therapeutic Innovation & Regulatory Science

Select article: Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-Sponsor Conferences

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Research article

First published 1997-7

Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-Sponsor Conferences

Joseph A. DiMasi, Michael Manocchia

Therapeutic Innovation & Regulatory Science

Select article: Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements

Open access

Research article

First published 2019

Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements

Ingrid Freije, Stéphane Lamouche, Mario Tanguay

Therapeutic Innovation & Regulatory Science

Select article: CANDA Overview: What Should a CANDA Look Like?

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Research article

First published 1993-4

CANDA Overview: What Should a CANDA Look Like?

William P. Accomando

Therapeutic Innovation & Regulatory Science

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