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Articles (60)

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1-10 of 60 results for NDA review

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Select article: Discussion Based on the Survey Results of Authorities' Inquiries during NDA Review in Japan

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Other

First published 2010-1

Discussion Based on the Survey Results of Authorities' Inquiries during NDA Review in Japan

Reiko Numazaki, Kazumi Sunamura, Chikara Kikuthi [...]

Therapeutic Innovation & Regulatory Science

Select article: Analysis of Review Times for Recent 505(b)(2) Applications

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Research article

First published 2017-9

Analysis of Review Times for Recent 505(b)(2) Applications

Sharon Sakai, Joseph A. DiMasi, Kenneth A. Getz

Therapeutic Innovation & Regulatory Science

Select article: The Interactive IND/NDA

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Research article

First published 1996-7

The Interactive IND/NDA

Loren Miller, Jill Buckley, Richard Crawley

Therapeutic Innovation & Regulatory Science

Select article: Best Practices for Communication between FDA and Applicants during the NDA Review Cycle: A PhRMA White Paper

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Other

First published 2008-1

Best Practices for Communication between FDA and Applicants during the NDA Review Cycle: A PhRMA White Paper

David M. Cocchetto, Jennifer L. Stotka, Diane Zezza [...]

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: {BLR 1472}Fda - Nda Reviews - User Fees

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News

First published 1993-05

{BLR 1472}Fda - Nda Reviews - User Fees

Biotechnology Law Report

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: NDA Day Strategy and Success for ICI Pharmaceuticals Group's Diprivan® (PROPOFOL)

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Research article

First published 1992-7

NDA Day Strategy and Success for ICI Pharmaceuticals Group's Diprivan® (PROPOFOL)

Gustavo Acosta, Nanette E. Holston

Therapeutic Innovation & Regulatory Science

Select article: Format and Content of a Statistical Data Item

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Research article

First published 1992-4

Format and Content of a Statistical Data Item

Rayanne S. Berman

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

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