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Articles (7)

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1-7 of 7 results for NDA review period

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Select article: Discussion Based on the Survey Results of Authorities' Inquiries during NDA Review in Japan

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First published 2010-1

Discussion Based on the Survey Results of Authorities' Inquiries during NDA Review in Japan

Reiko Numazaki, Kazumi Sunamura, Chikara Kikuthi [...]

Therapeutic Innovation & Regulatory Science

Select article: The December Effect in FDA Drug Approvals: Assessing the Submissions Echo Hypothesis

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First published 2007-9

The December Effect in FDA Drug Approvals: Assessing the Submissions Echo Hypothesis

James B. Graham, Ernst R. Berndt

Therapeutic Innovation & Regulatory Science

Select article: Recent Approaches by the PMDA to Promoting New Drug Development: Change in the Status of the PMDA in Relation to New Drug Development over the Last Five Years

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First published 2009-1

Recent Approaches by the PMDA to Promoting New Drug Development: Change in the Status of the PMDA in Relation to New Drug Development over the Last Five Years

Kazuhiko Mori, Sotoshi Toyoshima

Therapeutic Innovation & Regulatory Science

Select article: The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines

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First published 2001-1

The Effects of the Prescription Drug User Fee Act and the Food and Drug Administration Modernization Act on the Development and Approval of Therapeutic Medicines

Janice M. Reichert, Jennifer Chee, Claire S. Kotzampaltiris

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: 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: Factors Associated with Multiple FDA Review Cycles and Approval Phase Times

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First published 2009-3

Factors Associated with Multiple FDA Review Cycles and Approval Phase Times

Joseph A. DiMasi, Laura Faden

Therapeutic Innovation & Regulatory Science

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