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First published 1997-10

Good Statistics Practice in the Drug Development and Regulatory Approval Process

Shein-Chung Chow

Therapeutic Innovation & Regulatory Science

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Other

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

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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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Research article

First published 2015-11

The Relationship Between Development Start Lag and Approval Lag in Oncology Drug Development in Japan

Keitaro Nakajima, Ramzi Dagher, Laurie Strawn [...]

Therapeutic Innovation & Regulatory Science

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Other

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

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Research article

First published 2019-11

Clinical Development of Biologics Approved by the US Food and Drug Administration,2003-2016

G. Caleb Alexander, Ken Ogasawara, Dana Wiegand [...]

Therapeutic Innovation & Regulatory Science

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Other

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

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Other

First published 1999-4

The Evolving Paradigm for Clinical Development and Regulatory Approval of Antiretroviral Drugs in the United States

David M. Cocchetto, Lynn Smiley

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2019

Review of Drugs Approved via the 505(b)(2) Pathway: Uncovering Drug Development Trends and Regulatory Requirements

Ingrid Freije, Stéphane Lamouche, Mario Tanguay

Therapeutic Innovation & Regulatory Science

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Research article

First published 1994-1

Regulatory Strategy: A Blueprint for Drug Development

Loren L. Miller, Patricia P. Edgar, Vivian Lackey [...]

Therapeutic Innovation & Regulatory Science

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