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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

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 2016-11

A Bayesian Exposure-Time Method for Clinical Trial Safety Monitoring With Blinded Data

Patrick M. Schnell, Greg Ball

Therapeutic Innovation & Regulatory Science

Retricted access

Research article

First published 1986-7

System Integration of an Adverse Experience Thesaurus — Experience with a New Computer Methodology

Raymond L. Herman

Therapeutic Innovation & Regulatory Science

Open access

Research article

First published 2025-2

Physician-Patient Communication about Novel Drugs and High-Risk Medical Devices

Sanket S. Dhruva, Aaron S. Kesselheim, Steven Woloshin [...]

Medical Decision Making

Free access

Research article

First published 2005-5

Use of a Powered Shaver to Remove Multiple Oral Cavity Papillomas

Robert Sean Miller, Thomas A. Tami

Ear,Nose & Throat Journal

Retricted access

Other

First published 1998-4

A Preliminary Assessment of the Impact of MEDDRA on Adverse Event Reports and Product Labeling

Claudia A. White

Therapeutic Innovation & Regulatory Science

Open access

Case report

First published 2021

Acute motor axonal neuropathy after ipilimumab and nivolumab treatment in melanoma brain metastases: A case report and review of the literature

Yolanda Piña, Brittany R. Evernden, Nikhil Khushalani [...]

Sage Open Medical Case Reports

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