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1-10 of 554 results for Marketing authorization application

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Select article: Hybrid or Mixed Marketing Authorization Application in the European Union

Retricted access

Research article

First published 2012-7

Hybrid or Mixed Marketing Authorization Application in the European Union

Andreas M. Vogel

Therapeutic Innovation & Regulatory Science

Select article: Implementation of Structured Benefit-Risk Assessments in Marketing Authorization Applications

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Research article

First published 2016-11

Implementation of Structured Benefit-Risk Assessments in Marketing Authorization Applications

JuAn Wang, Anne Wolka, Kristin Bullok [...]

Therapeutic Innovation & Regulatory Science

Select article: One Module to Many Submissions: Generating Global Marketing Authorization Applications

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Other

First published 2000-7

One Module to Many Submissions: Generating Global Marketing Authorization Applications

Donna Morgan Murray, Susan M. Dansereau, Donna R. Park [...]

Therapeutic Innovation & Regulatory Science

Select article: Incorporation of a Benefit-Risk Assessment Framework Into the Clinical Overview of Marketing Authorization Applications

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Research article

First published 2016-1

Incorporation of a Benefit-Risk Assessment Framework Into the Clinical Overview of Marketing Authorization Applications

Anne Wolka, Margaret Warner, Kristin Bullok [...]

Therapeutic Innovation & Regulatory Science

Select article: DEVELOPING A DATABASE FOR AUTOMATING REGULATORY AFFAIRS IN THE PHARMACEUTICAL INDUSTRY

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Research article

First published 2005-11

DEVELOPING A DATABASE FOR AUTOMATING REGULATORY AFFAIRS IN THE PHARMACEUTICAL INDUSTRY

Lindi Slevin, Reza Shojanoori, Radmila Juric

Journal of Integrated Design and Process Science

Select article: Clinical Study Authorizations: Development Strategies

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Research article

First published 1990-7

Clinical Study Authorizations: Development Strategies

L. S. Kaufman, C. S. Snoddy

Therapeutic Innovation & Regulatory Science

Select article: Main Deficiencies concerning the European Marketing Authorization: Part II

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Other

First published 2001-4

Main Deficiencies concerning the European Marketing Authorization: Part II

Yvonne Legras

Therapeutic Innovation & Regulatory Science

Select article: The Format and Content of a Global Chemical/Pharmaceutical Documentation — A Proposal *

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Research article

First published 1995-10

The Format and Content of a Global Chemical/Pharmaceutical Documentation — A Proposal *

Anthony C. Cartwright, Manuel Zahn

Therapeutic Innovation & Regulatory Science

Select article: Impact of retrospective data verification to prepare the ICON6 trial for use in a marketing authorization application

Open access

Research article

First published 2019-10

Impact of retrospective data verification to prepare the ICON6 trial for use in a marketing authorization application

Andrew Embleton-Thirsk, Elizabeth Deane, Stephen Townsend [...]

Clinical Trials

Select article: An Overview and Comparison of the US and EEC Chemical and Pharmaceutical Requirements for the Marketing Authorization/New Drug Application

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Research article

First published 1989-7

An Overview and Comparison of the US and EEC Chemical and Pharmaceutical Requirements for the Marketing Authorization/New Drug Application

Kevin McKenna

Therapeutic Innovation & Regulatory Science

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