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Articles (7)

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1-7 of 7 results for expedited programs for serious conditions

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Select article: Breakthrough Therapy Designation

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Other

First published 2015-3

Breakthrough Therapy Designation

Arpita Shah

Therapeutic Innovation & Regulatory Science

Select article: The US Food and Drug Administration’s expedited approval programs: Evidentiary standards,regulatory trade-offs,and potential improvements

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Research article

First published 2018-6

The US Food and Drug Administration’s expedited approval programs: Evidentiary standards,regulatory trade-offs,and potential improvements

Joshua D Wallach, Joseph S Ross, Huseyin Naci

Clinical Trials

Select article: The Impact of Breakthrough Therapy Designation on Drug Safety

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Research article

First published 2025

The Impact of Breakthrough Therapy Designation on Drug Safety

Hanu Tyagi, Rachna Shah

Production and Operations Management

Select article: The Food and Drug Administration'S Fast Track Designation: Observations from the Initial Two Years of this Designation

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First published 2000-7

The Food and Drug Administration'S Fast Track Designation: Observations from the Initial Two Years of this Designation

David M. Cocchetto

Therapeutic Innovation & Regulatory Science

Select article: Breakthrough Therapy Designation

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Research article

First published 2017-7

Breakthrough Therapy Designation

Ryan Conrad, Kimberly Taylor, Miranda Raggio [...]

Therapeutic Innovation & Regulatory Science

Select article: Obinutuzumab for chronic lymphocytic leukemia: promise of the first treatment approved with breakthrough therapy designation

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Review article

First published 2015-10

Obinutuzumab for chronic lymphocytic leukemia: promise of the first treatment approved with breakthrough therapy designation

Ashish Kumar Kakkar, Sadasivam Balakrishnan

Journal of Oncology Pharmacy Practice

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

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