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Other

First published 2008-7

Preparing Regulatory Submissions with the FDA Reviewer in Mind: Use of the Clinical Review Template and Clinical Safety Reviewer Guidance by Sponsors

Mary Vanderhoof, Michael J. Umen, David N. Schwartz

Therapeutic Innovation & Regulatory Science

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Other

First published 2005-12

Care Pathway for TNF α-Blockers for Patients with Rheumatoid Arthritis at the Royal National Hospital for Rheumatic Diseases

Nicholas Shenker, Chris Fokke, Elizabeth Michell

International Journal of Care Coordination

Retricted access

Research article

First published 2015-5

Choosing Appropriate Metrics to Evaluate Adverse Events in Safety Evaluation

Ying Zhou, Chunlei Ke, Qi Jiang [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2008-9

Preparing your Hospital for Compliance with the Joint Commission's National Patient Safety Goals

Lee Murdaugh, Robert Jordin

Hospital Pharmacy

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Other

First published 2002-11

Commentary: Making "Me-too" Drugs Benefit the Public

Neil J. Nusbaum

American Journal of Medical Quality

Open access

Research article

First published 2014-7

Investigators’ Experience With Expedited Safety Reports Prior to the FDA’s Final IND Safety Reporting Rule

Judith M. Kramer, David Vock, Howard E. Greenberg [...]

Therapeutic Innovation & Regulatory Science

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Research article

First published 2021-11

Acupuncture for Cancer-Related Constipation: A Protocol for Systematic Review and Meta-Analysis

Jing Xu, Yupei Chen, Yuzhuo Bai [...]

Acupuncture & Electro-Therapeutics Research: International Journal of Integrated Medicine

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Other

First published 2010-9

Statistical Considerations for the Efficacy Assessment of Clinical Studies of Vulvar and Vaginal Atrophy

Ling Chen, Moh-Jee Ng, Theresa H. van der Vlugt [...]

Therapeutic Innovation & Regulatory Science

Open access

Review article

First published 2025-01

Pharmacological management of chronic insomnia disorder in Singapore: Recommendations from an expert panel

Roger Ho, Chau Sian Lim, Phern Chern Tor [...]

Proceedings of Singapore Healthcare

Free access

Research article

First published 1999-01

Safety Assessment of Biotechnology-Derived Pharmaceuticals: ICH and Beyond

Mercedes A. Serabian, Anne M. Pilaro

Toxicologic Pathology

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