Sage Journals: Discover world-class research

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Research article

First published 2009-8

Understanding FDA Regulatory Requirements for Investigational New Drug Applications for Sponsor-Investigators

M. E. Blair Holbein

Journal of Investigative Medicine

Open access

Research article

First published 2017-6

Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

Raymond Perez, Patrick Archdeacon, Nancy Roach [...]

Clinical Trials

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Research article

First published 2014-6

Recommendations from the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium: Developing and Implementing a Sponsor-Investigators Training Program

M. E. Blair Holbein, Jelena Petrovic Berglund, Erin K. O'Reilly [...]

Journal of Investigative Medicine

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Other

First published 2001-4

Should Global Clinical Studies be Conducted under the United States Investigational New Drug Application?

Thomas J. Kirsch, Graham Burton

Therapeutic Innovation & Regulatory Science

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Research article

First published 1972-11

Preclinical Principles of the Investigation of New Drugs

F J Sanen

Journal of International Medical Research

Open access

Research article

First published 2014-3

Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application

Patrick Archdeacon, Cheryl Grandinetti, José M. Vega [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 1977-8

Worldwide Regulatory Requirements and their Effects on the Clinical Study and Transport of Investigational New Drugs

Bernard A. Haines

Annals of Pharmacotherapy

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Research article

First published 2017-9

Investigation of the Factors Affecting Risk-Based Quality Management of Investigator-Initiated Investigational New-Drug Trials for Unapproved Anticancer Drugs in Japan

Tomohisa Sudo, Akihiro Sato

Therapeutic Innovation & Regulatory Science

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Other

First published 1998-10

An Overview of the Regulatory Approval Process in Drug Development

Shein-Chung Chow, Annpey Pong

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2024-9

Rapid Identification of Suspected Drug Overdose Deaths by Death Investigators,New Jersey,2020

Karli R. Hochstatter, Marlon Williams, Shanna Latham [...]

Public Health Reports®

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