Search results: Sage Journals

Open accessEditorialFirst published 2025

Organoids in biomedicine: Bridging innovation,disease modeling,and regulatory transformation

Chunhui Cai, Xinxin Han

Cell Transplantation

Open accessResearch articleFirst published April, 2025

A reflection on paradigmatic tensions within the FDA advisory committee for MDMA-assisted therapy

Leor Roseman

Journal of Psychopharmacology

Free accessResearch articleFirst published September, 2022

FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products

Daniel Eisenman, Scott Swindle

Applied Biosafety

Restricted accessResearch articleFirst published June, 2017

A decade of natalizumab and PML: Has there been a tacit transfer of risk acceptance?

David B Clifford, Tarek A Yousry, Eugene O Major

Multiple Sclerosis Journal

Restricted accessReview articleFirst published January, 2014

Multiple Sclerosis Outcome Assessments Consortium: Genesis and initial project plan

Richard A Rudick, Nicholas LaRocca, Lynn D Hudson [...]

Multiple Sclerosis Journal

Restricted accessResearch articleFirst published September, 2018

Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review

Samuel A. Bonet, Farzan Sasangohar, Mark Lawley

Proceedings of the Human Factors and Ergonomics Society Annual Meeting

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 accessReview articleFirst published April, 2025

Scale-Up and Postapproval Changes in Orally Inhaled Drug Products: Scientific and Regulatory Considerations

Gur Jai Pal Singh, S. Prasad Peri

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Open accessReview articleFirst published 2026

From policy to practice: Evaluating the global implications of the FDA’s PDURS framework

Yingbo Zhang, Li Shen, Shan He [...]

DIGITAL HEALTH

Open accessResearch articleFirst published 2020

2019: A year of expansion in psychedelic research,industry,and deregulation

Jacob S Aday, Emily K Bloesch, Christopher C Davoli

Drug Science,Policy and Law

Open accessEditorialFirst published 2025

Organoids in biomedicine: Bridging innovation,disease modeling,and regulatory transformation

Chunhui Cai, Xinxin Han

Cell Transplantation

Open accessResearch articleFirst published April, 2025

A reflection on paradigmatic tensions within the FDA advisory committee for MDMA-assisted therapy

Leor Roseman

Journal of Psychopharmacology

Free accessResearch articleFirst published September, 2022

FDA Guidance on Shedding and Environmental Impact in Clinical Trials Involving Gene Therapy Products

Daniel Eisenman, Scott Swindle

Applied Biosafety

Restricted accessResearch articleFirst published June, 2017

A decade of natalizumab and PML: Has there been a tacit transfer of risk acceptance?

David B Clifford, Tarek A Yousry, Eugene O Major

Multiple Sclerosis Journal

Restricted accessReview articleFirst published January, 2014

Multiple Sclerosis Outcome Assessments Consortium: Genesis and initial project plan

Richard A Rudick, Nicholas LaRocca, Lynn D Hudson [...]

Multiple Sclerosis Journal

Restricted accessResearch articleFirst published September, 2018

Investigating the Food and Drug Administration (FDA) Biotherapeutics Review and Approval Process: A Scoping Review

Samuel A. Bonet, Farzan Sasangohar, Mark Lawley

Proceedings of the Human Factors and Ergonomics Society Annual Meeting

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 accessReview articleFirst published April, 2025

Scale-Up and Postapproval Changes in Orally Inhaled Drug Products: Scientific and Regulatory Considerations

Gur Jai Pal Singh, S. Prasad Peri

Journal of Aerosol Medicine and Pulmonary Drug Delivery

Open accessReview articleFirst published 2026

From policy to practice: Evaluating the global implications of the FDA’s PDURS framework

Yingbo Zhang, Li Shen, Shan He [...]

DIGITAL HEALTH

Open accessResearch articleFirst published 2020

2019: A year of expansion in psychedelic research,industry,and deregulation

Jacob S Aday, Emily K Bloesch, Christopher C Davoli

Drug Science,Policy and Law