Sage Journals: Discover world-class research

Open access

Research article

First published 2017-6

Sponsors’ and investigative staffs' perceptions of the current investigational new drug safety reporting process in oncology trials

Raymond Perez, Patrick Archdeacon, Nancy Roach [...]

Clinical Trials

Open access

Review article

First published 2024

Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation

Antonio Lomeli-Silva, Homero Contreras-Salinas, Mayra Yolanda Barajas-Virgen [...]

Therapeutic Advances in Drug Safety

Retricted access

Review article

First published 2026-2

The Safety and Utility of Early Swallow Assessment Using Flexible Endoscopic Evaluation of Swallowing (FEES) in Patients Requiring Extra Corporeal Membrane Oxygenation (ECMO): A Case Series (Four Reports)

Eleanor Dixon, Sarah Wallace

Advances in Communication and Swallowing

Retricted access

Research article

First published 1996-1

Population Exposure Required to Assess Clinical Safety: Report to the International Conference on Harmonization Working Group *

Jeffrey S. Brown, Kenneth I. Kaitin, Neil McAuslane [...]

Therapeutic Innovation & Regulatory Science

Free access

Research article

First published 2002-06

Programmable electronic medical systems – related risks and learning from accidents

F. Koornneef, U. Voges

Health Informatics Journal

Retricted access

Research article

First published 2006-06

GAO Criticizes FDA on Drug Safety: FDA Extends Indications for Erbitux: First Generic rDNA Product Approved in Europe: Safety Data to Be Required in Electronic Form: Report Card on Postmarketing Studies: International Guidelines Proposed for Stem Cell Research: France Chided for Tardiness in GM Legislation

Biotechnology Law Report

Retricted access

Research article

First published 1993-10

Phase IIIB and Treatment IND Safety Reporting

Gerald A. Faich

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 1997-1

Clinical Trial Safety Surveillance in the New Regulatory and Harmonization Environment: Lessons Learned from the “Fialuridine Crisis”

James Nickas

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2014-3

Optimizing Expedited Safety Reporting for Drugs and Biologics Subject to an Investigational New Drug Application

Patrick Archdeacon, Cheryl Grandinetti, José M. Vega [...]

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 1987-7

Investigational Adverse Experience Reporting

Robert A. Michalak

Therapeutic Innovation & Regulatory Science

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