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1-10 of 67 results for Accelerated Approval Designation

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Select article: Pulmonary Arterial Hypertension: A Case Study in FDA Expedited Program Designations

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Research article

First published 2019-3

Pulmonary Arterial Hypertension: A Case Study in FDA Expedited Program Designations

Iraj Daizadeh

Therapeutic Innovation & Regulatory Science

Select article: Accelerated Pathways Work—Now What? A Survey of Payers in the United States

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Research article

First published 2017-3

Accelerated Pathways Work—Now What? A Survey of Payers in the United States

Barry Farrimond, Jonathan J. Fleming, Mark Mathieu

Therapeutic Innovation & Regulatory Science

Select article: FDA’s Expedited Programs and Their Impact on the Availability of New Therapies

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Research article

First published 2017-1

FDA’s Expedited Programs and Their Impact on the Availability of New Therapies

Nehar Damle, Shilvi Shah, Praneeta Nagraj [...]

Therapeutic Innovation & Regulatory Science

Select article: Emerging Trends in US Oncological Approvals: A 13-Year Review (1999-2011)

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First published 2012-5

Emerging Trends in US Oncological Approvals: A 13-Year Review (1999-2011)

Jing Huang, Wenze Zhang, Debra Bowen [...]

Therapeutic Innovation & Regulatory Science

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: Integration of Information and Automation Technologies in Bridge Engineering and Management

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Research article

First published 2006

Integration of Information and Automation Technologies in Bridge Engineering and Management

Stuart S. Chen, Arun M. Shirolé

Transportation Research Record: Journal of the Transportation Research Board

Select article: Fast Track Product Designation under the Food and Drug Administration Modernization Act: The Industry Experience

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Other

First published 2001-1

Fast Track Product Designation under the Food and Drug Administration Modernization Act: The Industry Experience

Christopher-Paul Milne, Elaine Bergman

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

Select article: Accelerator based epithermal neutron source for clinical boron neutron capture therapy

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Research article

First published 2022-12

Accelerator based epithermal neutron source for clinical boron neutron capture therapy

Naonori Hu, Hiroki Tanaka, Kazuhiko Akita [...]

Journal of Neutron Research

Select article: Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022

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Research article

First published 2025-6

Pivotal trial characteristics and types of endpoints used to support Food and Drug Administration rare disease drug approvals between 2013 and 2022

Kyungwan Hong, Bridget Nugent, Abbas Bandukwala [...]

Clinical Trials

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