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Tag: Benefit-risk assessment

This online library aims to help users find a variety of annotated resources about patient engagement to help them launch patient-centered efforts, enhance existing programs or identify where more work is needed. To suggest an item to be included, contact Taylor Cusher of FasterCures here.

Benefit-Risk Assessment in Pharmaceutical Research and Development

CRC Press

This book provides a overview of the key considerations relevant to benefit-risk assessment across the R&D spectrum, from early clinical...

Benefit-risk assessment

Patient Information Tool & Implementation Guide

National Health Council

This tool was developed to help patient organizations collect and organize issues of interest to potential medical product developers and...

Benefit-risk assessment Patient organizations Patient focused drug development

Patient-Focused Drug Development Initiative

FDA Center for Drug Evaluation and Research

Information about the FDA's Patient-Focused Drug Development initiative that aims to more systematically gather patients’ perspectives on their condition and...

Benefit-risk assessment Patient focused drug development

Lifecycle Approach to FDA's Structured Benefit-Risk Assessment


This white paper identifies considerations for biopharmaceutical companies using FDA's Structured Benefit-Risk Assessment Framework throughout a product's lifecycle, including steps...

Benefit-risk assessment