Search results: Sage Journals

Restricted accessResearch articleFirst published February, 2018

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

Christopher B. Shook, Mikyung Kim

Biotechnology Law Report

Restricted accessEditorialFirst published September, 2018

From the Valley of Death to the Crossroads of Opportunity

Peter J. Pitts, Patrick Brady

Therapeutic Innovation & Regulatory Science

Restricted accessEditorialFirst published July, 2018

Advancing Drug Safety Through Prospective Pharmacovigilance

Peter J. Pitts, Hervé Le Louet

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published November, 2018

Regional Approaches to Expedited Drug Development and Review

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

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published December, 2025

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

Restricted accessResearch articleFirst published June, 2018

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

Restricted accessBrief reportFirst published September 9, 2011

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

Restricted accessResearch articleFirst 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

Restricted accessResearch articleFirst published June, 2026

The Impact of Breakthrough Therapy Designation on Drug Safety

Hanu Tyagi, Rachna Shah

Production and Operations Management

Restricted accessResearch articleFirst published January, 2017

Prolonged Motor Block following Epidural Anaesthesia: A Proposed Pathway for Investigation and Management to Facilitate Rapid MRI Scanning to Exclude Vertebral Canal Haematoma

S Bampoe, S De Silva, M Scott

Journal of Perioperative Practice

Restricted accessResearch articleFirst published February, 2018

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

Christopher B. Shook, Mikyung Kim

Biotechnology Law Report

Restricted accessEditorialFirst published September, 2018

From the Valley of Death to the Crossroads of Opportunity

Peter J. Pitts, Patrick Brady

Therapeutic Innovation & Regulatory Science

Restricted accessEditorialFirst published July, 2018

Advancing Drug Safety Through Prospective Pharmacovigilance

Peter J. Pitts, Hervé Le Louet

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published November, 2018

Regional Approaches to Expedited Drug Development and Review

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

Therapeutic Innovation & Regulatory Science

Restricted accessResearch articleFirst published December, 2025

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

Restricted accessResearch articleFirst published June, 2018

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

Restricted accessBrief reportFirst published September 9, 2011

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

Restricted accessResearch articleFirst 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

Restricted accessResearch articleFirst published June, 2026

The Impact of Breakthrough Therapy Designation on Drug Safety

Hanu Tyagi, Rachna Shah

Production and Operations Management

Restricted accessResearch articleFirst published January, 2017

Prolonged Motor Block following Epidural Anaesthesia: A Proposed Pathway for Investigation and Management to Facilitate Rapid MRI Scanning to Exclude Vertebral Canal Haematoma

S Bampoe, S De Silva, M Scott

Journal of Perioperative Practice