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Research article

First published 2018-9

Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review

Samuel A. Bonet, Farzan Sasangohar, Mark Lawley

Proceedings of the Human Factors and Ergonomics Society Annual Meeting

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Research article

First published 1996-7

The Interactive IND/NDA

Loren Miller, Jill Buckley, Richard Crawley

Therapeutic Innovation & Regulatory Science

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Research article

First published 2012-1

Improving Time to Pharmaceutical Approval

Andrea C. Masciale, Patricia L. DeSantis, Jay P. Siegel

Therapeutic Innovation & Regulatory Science

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Research article

First published 2021-12

Understanding Constraints and Enablers of Turnaround Time for Ethics Review: The Case of Institutional Review Boards in Tanzania

Mwifadhi Mrisho, Zaynab Essack

Journal of Empirical Research on Human Research Ethics

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Review article

First published 2013-06

Lessons Learned from the Clinical Development and Market Authorization of Glybera

Laura M. Bryant, Devin M. Christopher, April R. Giles [...]

Human Gene Therapy Clinical Development

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Other

First published 1987-10

The Drug Approval Process and the Information it Provides

Ann Myers, Steven R. Moore, Abraham G. Hartzema [...]

Annals of Pharmacotherapy

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Other

First published 1999-1

The Regulatory Approval Process of Animal Drugs

Stephen J. Gilbride, Michael J. McGowan

Therapeutic Innovation & Regulatory Science

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Review article

First published 1989-09

Book Review : Multiple Scaling Samuel Shye Amsterdam: North-Holland,1985,337 pp.,approx. $94.75. The Facet Analytic Approach to Research and Data Processing Aharon E. Tziner New York: Peter Lang,1987,137 pp.,approx. $30.00

Roderick P. McDonald

Applied Psychological Measurement

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Other

First published 2007-5

A Comparison of the Drug Review Process at Five International Regulatory Agencies

Mayu Hirako, Neil McAuslane, Sam Salek [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2015-04

Development of Drug-Approval Regulations for Medical Countermeasures Against CBRN Agents in Japan

Rumiko Shimazawa, Masayuki Ikeda

Health Security

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