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Articles (68)

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1-10 of 68 results for expedited pathways

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Select article: Ensuring Expeditious Entry: Korea and the U.S. Regulatory Pathway for Bringing Biosimilars to Market

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Research article

First published 2018-02

Ensuring Expeditious Entry: Korea and the U.S. Regulatory Pathway for Bringing Biosimilars to Market

Christopher B. Shook, Mikyung Kim

Biotechnology Law Report

Select article: From the Valley of Death to the Crossroads of Opportunity

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Editorial

First published 2018-9

From the Valley of Death to the Crossroads of Opportunity

Peter J. Pitts, Patrick Brady

Therapeutic Innovation & Regulatory Science

Select article: Advancing Drug Safety Through Prospective Pharmacovigilance

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Editorial

First published 2018-7

Advancing Drug Safety Through Prospective Pharmacovigilance

Peter J. Pitts, Hervé Le Louet

Therapeutic Innovation & Regulatory Science

Select article: Regional Approaches to Expedited Drug Development and Review

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Research article

First published 2018-11

Regional Approaches to Expedited Drug Development and Review

Elizabeth Richardson, Gregory Daniel, David R. Joy [...]

Therapeutic Innovation & Regulatory Science

Select article: Feasibility of Expedited Home Sleep Testing Before Surgery for Detection of High-Risk Sleep-Related Breathing Disorders

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Research article

First published 2025-12

Feasibility of Expedited Home Sleep Testing Before Surgery for Detection of High-Risk Sleep-Related Breathing Disorders

Mehraneh Khalighi, Lucas M. Donovan, Ken He [...]

Respiratory Care

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: TNF and Leptin Tell Essentially the Same Story in Alzheimer's Disease

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Brief report

First published 2011-9-9

TNF and Leptin Tell Essentially the Same Story in Alzheimer's Disease

Ian A. Clark, Lisa M. Alleva, Bryce Vissel

Journal of Alzheimer’s Disease

Select article: A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways

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Research article

First published 2018

A Proposed Framework for a Globally Applicable Pragmatic Approach to Using Facilitated Regulatory Pathways

Lawrence Liberti, Neil McAuslane, Pieter Stolk [...]

Therapeutic Innovation & Regulatory Science

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: 21st-Century Oncology Drug Safety via New-Age Regulatory Standards and Practices

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Article commentary

First published 2019-9

21st-Century Oncology Drug Safety via New-Age Regulatory Standards and Practices

Peter J. Pitts, Hervé Le Louet, Gregory Katz

Therapeutic Innovation & Regulatory Science

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