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1-10 of 58 results for Electronic new drug application

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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: What is the Future of the Canda at FDA?

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Research article

First published 1994-4

What is the Future of the Canda at FDA?

Robert A. Bell

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

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: Submitting Biologics Applications to the Center for Biologics Evaluation and Research Electronically

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First published 1999-1

Submitting Biologics Applications to the Center for Biologics Evaluation and Research Electronically

Mary A. Buesing, Edward McSweegan

Therapeutic Innovation & Regulatory Science

Select article: Regulatory Submissions: From CANDA/CAPLA to 2002 and Beyond

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First published 2000-7

Regulatory Submissions: From CANDA/CAPLA to 2002 and Beyond

Ross Raymond, Susan Galle, William Collom

Therapeutic Innovation & Regulatory Science

Select article: Electronic Common Technical Document Implementation in Japan

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First published 2009-7

Electronic Common Technical Document Implementation in Japan

Kiyohito Nakai, Yasuhiro Araki, Daigoro Ebina [...]

Therapeutic Innovation & Regulatory Science

Select article: Lek's Approach to CAANDAs

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First published 1995-4

Lek's Approach to CAANDAs

Matevž Kmet, Mirjam Šopar-Urleb

Therapeutic Innovation & Regulatory Science

Select article: Ultrastructural localization of phenothiazines and tetracycline: a new histochemical approach.

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Abstract

First published 1983-5

Ultrastructural localization of phenothiazines and tetracycline: a new histochemical approach.

S F Hoff, A J MacInnis

Journal of Histochemistry & Cytochemistry

Select article: The Challenge of Global Electronic Submission Standards in the Biopharmaceutical Industry

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First published 1998-7

The Challenge of Global Electronic Submission Standards in the Biopharmaceutical Industry

Ronald D. Fitzmartin

Therapeutic Innovation & Regulatory Science

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