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Articles (54)

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1-10 of 54 results for drug regulatory affairs

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Select article: Can Regulatory Affairs Personnel Add Value When the Goal is Increasing Speed of Drug Development?

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Research article

First published 1995-10

Can Regulatory Affairs Personnel Add Value When the Goal is Increasing Speed of Drug Development?

David M. Cocchetto

Therapeutic Innovation & Regulatory Science

Select article: Drug Metabolism in Drug Development: A DIA Tutorial for Regulatory Affairs Specialists *

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Other

First published 1998-1

Drug Metabolism in Drug Development: A DIA Tutorial for Regulatory Affairs Specialists *

Peter K. Honig, Louis R. Cantilena, Kenneth S. Santone

Therapeutic Innovation & Regulatory Science

Select article: The Regulatory Affairs Professional in the “Hot Seat” in the Drug Development Process

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Research article

First published 1997-7

The Regulatory Affairs Professional in the “Hot Seat” in the Drug Development Process

Loren L. Miller, David M. Cocchetto

Therapeutic Innovation & Regulatory Science

Select article: The FDA's Medical Dictionary for Drug Regulatory Affairs Alpha Test

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Research article

First published 1995-10

The FDA's Medical Dictionary for Drug Regulatory Affairs Alpha Test

Kathryn Huntley, Mary Jo Veverka, Minna Golden

Therapeutic Innovation & Regulatory Science

Select article: Bringing Information on Evolving FDA Standards to Bear on Ongoing Drug Development Programs

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First published 1999-7

Bringing Information on Evolving FDA Standards to Bear on Ongoing Drug Development Programs

Larry R. Versteegh, Lynne M. Tracey

Therapeutic Innovation & Regulatory Science

Select article: Bringing Information on Evolving FDA Standards to Bear on Ongoing Drug Development Programs

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Research article

First published 1995-10

Bringing Information on Evolving FDA Standards to Bear on Ongoing Drug Development Programs

Larry R. Versteegh

Therapeutic Innovation & Regulatory Science

Select article: An Experimental Model of Regulatory Science in Asia: Center for Drug Evaluation in Taiwan

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First published 2009-5

An Experimental Model of Regulatory Science in Asia: Center for Drug Evaluation in Taiwan

Herng-Der Chern, Churn-Shiouh Gau, Hsu-Mei Hsu Chen [...]

Therapeutic Innovation & Regulatory Science

Select article: Session A — Drug Regulatory Affairs: Questions and Answers

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Research article

First published 1981-7

Session A — Drug Regulatory Affairs: Questions and Answers

Therapeutic Innovation & Regulatory Science

Select article: {BLR 2991} Biofilms – Drug Resistance – Regulatory Affairs- S. aureus –Tuberculosis

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News

First published 1999-10

{BLR 2991} Biofilms – Drug Resistance – Regulatory Affairs- S. aureus –Tuberculosis

Biotechnology Law Report

Select article: Clinical Development of Biologics Approved by the US Food and Drug Administration,2003-2016

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Research article

First published 2019-11

Clinical Development of Biologics Approved by the US Food and Drug Administration,2003-2016

G. Caleb Alexander, Ken Ogasawara, Dana Wiegand [...]

Therapeutic Innovation & Regulatory Science

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