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First published 2008-1

A PhRMA Survey of Tracking and Reporting of Postmarketing Commitments

Michelle Folz, Mark Bokelman, Thomas H. Hassall [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2011-9

Results of a Survey of PhRMA Member Companies on Practices Associated with Multiregional Clinical Trials

Nick Scott, Bruce Binkowitz, Ekopimo Okon Ibia [...]

Therapeutic Innovation & Regulatory Science

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First published 2010-7

PhRMA BioResearch Monitoring Committee Perspective on Acceptable Approaches for Clinical Trial Monitoring

Roland W. Usher

Therapeutic Innovation & Regulatory Science

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First published 2006-12

Phrma Working Group on Adaptive Designs: Introduction to the Full White Paper

Paul Gallo, Michael Krams

Therapeutic Innovation & Regulatory Science

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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

Free access

Research article

First published 2008-7

Nonclinical Aspects of Biopharmaceutical Development: Discussion of Case Studies at a PhRMA-FDA Workshop

L. A. Buckley, K. Benson, K. Davis-Bruno [...]

International Journal of Toxicology

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Research article

First published 2013-06

PhRMA,BIO Critical of New Clinical Trial Rules

Biotechnology Law Report

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Research article

First published 2011-9

Points to Consider in Defining Region for a Multiregional Clinical Trial: Defining Region Work Stream in PhRMA MRCT Key Issue Team

Yoko Tanaka, Carmen Mak, Brent Burger [...]

Therapeutic Innovation & Regulatory Science

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First published 2008-1

Best Practices for the Advisory Committee Process for Products Regulated by CDER and CBER: A PhRMA White Paper

David M. Cocchetto, Thomas H. Hassall, Linda Carter [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2011-9

Consistency of Treatment Effect across Regions in Multiregional Clinical Trials,Part 1: Design Considerations

Joshua Chen, Hui Quan, Paul Gallo [...]

Therapeutic Innovation & Regulatory Science

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