Sage Journals: Discover world-class research

Open access

Editorial

First published 2025

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

Chunhui Cai, Xinxin Han

Cell Transplantation

Open access

Research article

First published 2025-4

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

Leor Roseman

Journal of Psychopharmacology

Free access

Research article

First published 2022-09

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

Daniel Eisenman, Scott Swindle

Applied Biosafety

Retricted access

Research article

First published 2017-6

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

Retricted access

Review article

First published 2014-1

Multiple Sclerosis Outcome Assessments Consortium: Genesis and initial project plan

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

Multiple Sclerosis Journal

Retricted access

Research article

First published 2018-9

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

Retricted access

Editorial

First published 2018-9

From the Valley of Death to the Crossroads of Opportunity

Peter J. Pitts, Patrick Brady

Therapeutic Innovation & Regulatory Science

Retricted access

Review article

First published 2025-04

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 access

Review article

First 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 access

Research article

First 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

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