Sage Journals: Discover world-class research

Free access

Review article

First published 2013-10

Preparing for safety issues following drug approval: pre-approval risk management considerations

Gretchen S. Dieck, Robert G. Sharrar

Therapeutic Advances in Drug Safety

Retricted access

Research article

First published 2017-7

Pre-approval Access Terminology

Laura L. Kimberly, Marc M. Beuttler, Michael Shen [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 1994-10

Demonstrating the Effectiveness of the Quality Systems for An FDA Pre-NDA Approval Inspection

David Johnston

Therapeutic Innovation & Regulatory Science

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Research article

First published 1982-10

Pre-NDA Approval Promotion — the View of an in-House Counsel

Robert E. Kamm

Therapeutic Innovation & Regulatory Science

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Other

First published 1998-7

The “N” in Pain is Silent: One Company's Approach to FDA Prenda Approval Inspections

Martin D. Hynes, Richard M. Justice, Jole O. Rodriguez [...]

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2024

Biomarkers From Discovery to Clinical Application: In Silico Pre-Clinical Validation Approach in the Face of Lung Cancer

Medi Kori, Esra Gov, Kazim Yalcin Arga [...]

Biomarker Insights

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Research article

First published 2025-9

Navigating nutraceuticals regulation: A comparative assessment of the USA and India

Fazal M. Tai, Alishanaz I. Subedar, M. Hasan Harsoliya [...]

Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector

Retricted access

Other

First published 2011-6

Major Tribunal Decisions in 2010

Joseph Catanzariti, Simon Brown

Journal of Industrial Relations

Retricted access

Other

First published 2013-9

Preapproval of Sinus Computed Tomography for Evaluation of Chronic Rhinosinusitis Does Not Save Healthcare Costs

Ahmad R. Sedaghat, Stacey T. Gray, David A. Kieff

Otolaryngology–Head and Neck Surgery

Retricted access

Research article

First published 1983-4

Peer Tutoring Effects on the Music Performance of Tutors and Tutees in Beginning Band Classes

Lucille Alexander, Laura G. Dorow

Journal of Research in Music Education

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