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Articles (34)

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1-10 of 34 results for United States Investigational New Drug Application

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

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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

Select article: An Overview of the Regulatory Approval Process in Drug Development

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First published 1998-10

An Overview of the Regulatory Approval Process in Drug Development

Shein-Chung Chow, Annpey Pong

Therapeutic Innovation & Regulatory Science

Select article: The New Drug Approvals of 1999,2000,and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992

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First published 2003-10

The New Drug Approvals of 1999,2000,and 2001: Drug Development Trends a Decade after Passage of the Prescription Drug User Fee Act of 1992

Kenneth I. Kaitin, Catherine Cairns

Therapeutic Innovation & Regulatory Science

Select article: The New Drug Approvals of 1996,1997,and 1998: Drug Development Trends in the User Fee Era *

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First published 2000-1

The New Drug Approvals of 1996,1997,and 1998: Drug Development Trends in the User Fee Era *

Kenneth I. Kaitin, Elaine M. Healy

Therapeutic Innovation & Regulatory Science

Select article: FDA Inspection of Investigator Sites in Italy

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Research article

First published 1997-1

FDA Inspection of Investigator Sites in Italy

N. Brunetti, M. Roncolato, S. Zancan

Therapeutic Innovation & Regulatory Science

Select article: Regulatory Issues of Importance to Developing Anti-HIV Therapeutics

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First published 1996-05

Regulatory Issues of Importance to Developing Anti-HIV Therapeutics

Kenneth L. Hastings

Toxicologic Pathology

Select article: FDA Inspection of Clinical Research Sponsors and Investigators: Avoiding the Pitfalls

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Research article

First published 1988-4

FDA Inspection of Clinical Research Sponsors and Investigators: Avoiding the Pitfalls

C. Stephen Lawrence

Therapeutic Innovation & Regulatory Science

Select article: Regulations Guiding the Interstate Shipment of Investigational Product

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Research article

First published 2014-2

Regulations Guiding the Interstate Shipment of Investigational Product

Chelsey McIntyre

Journal of Pharmacy Practice

Select article: Influence of Expedited Programs in the United States on Oncology Drug Development in Japan

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Research article

First published 2019-3

Influence of Expedited Programs in the United States on Oncology Drug Development in Japan

Makoto Tanaka, Naoki Matsumaru, Katsura Tsukamoto

Therapeutic Innovation & Regulatory Science

Select article: An Historical Perspective of the Successful Development of Sevoflurane

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First published 1998-1

An Historical Perspective of the Successful Development of Sevoflurane

Clair Callan, Leticia Delgado-Herrera, David Guzek [...]

Therapeutic Innovation & Regulatory Science

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