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Retricted access

Research article

First published 1992-1

Worldwide Regulations for Manufacturers on Clinical Safety Surveillance of Drugs

Arnold J. Gordon, Robert J. Petrick

Therapeutic Innovation & Regulatory Science

Retricted access

Other

First published 1992-10

An Industry Perspective on the State of Confusion in International ADR Reporting: Current Requirements and Attempts at Standardization

Arnold J. Gordon

Therapeutic Innovation & Regulatory Science

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

Free access

Review article

First published 2013-10

Monitoring product safety in the postmarketing environment

Robert G Sharrar, Gretchen S Dieck

Therapeutic Advances in Drug Safety

Retricted access

Case report

First published 2025

Novel Tissue-Engineered Amniotic Dressing for Chronic Wound Healing

Pengwen Ni, Kefeng Zhang, Xin Wu [...]

The International Journal of Lower Extremity Wounds

Open access

Research article

First published 2025

A multicenter,postmarketing surveillance of elobixibat in patients with chronic constipation in Japan: A final analysis report

Atsushi Nakajima, Minami Umeyama, Masaaki Higashikawa [...]

Sage Open Medicine

Retricted access

Research article

First published 2013-1

Regulatory Reforms in India

Deepti Sanghavi

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 2018-09

Development of Methodology and Study Protocol: Safety and Efficacy of a Single Subretinal Injection of rAAV.hCNGA3 in Patients with CNGA3 -Linked Achromatopsia Investigated in an Exploratory Dose-Escalation Trial

Nadine A. Kahle, Tobias Peters, Ditta Zobor [...]

Human Gene Therapy Clinical Development

Open access

Case report

First published 2025-4

Coin retained in the upper esophagus for more than 4 years: A case report and literature review

Hassan Assiri, Waleed Alshareef, Bshair Aldriweesh [...]

Ear,Nose & Throat Journal

Retricted access

Research article

First published 2020-1

Sign in,time out,sign out checklist-changing practice through interdepartmental teamwork to improve safety at caesarean section

Roisin Lennon, Alison Smith

Journal of Perioperative Practice

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