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Retricted access

Research article

First published 1996-7

New York City Pharmacists and Prospective Drug Utilization Review under Obra '90

Martha M. Rumore, Stanley Feifer, Joseph S. Rumore

Therapeutic Innovation & Regulatory Science

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Research article

First published 2007-7

US FDA Question-Based Review for Generic Drugs: A New Pharmaceutical Quality Assessment System

Lawrence X. Yu, Andre Raw, Robert Lionberger [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

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Research article

First published 2019-3

Strategic Shift of Statistical Review on Data Quality Assessment for New Drug Applications in China

Jun Wang, Gang Wang, Min Li [...]

Therapeutic Innovation & Regulatory Science

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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

Open access

Research article

First published 2018-3

Translating New Science Into the Drug Review Process

Rodney Rouse, Naomi Kruhlak, James Weaver [...]

Therapeutic Innovation & Regulatory Science

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Other

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

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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

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Research article

First published 1988-1

Use of Advisory Committees,Consultants,and Academic Reviewers by Drug Regulatory Authorities

D. H. Lawson

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 1994-04

An Examination of the Drug Review Process Within the United States

Phillip A. Johns

International Journal of Toxicology

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Research article

First published 1997-7

Initiatives to Speed New Drug Development and Regulatory Review: The Impact of FDA-Sponsor Conferences

Joseph A. DiMasi, Michael Manocchia

Therapeutic Innovation & Regulatory Science

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