Benefit-Risk

Patient perspectives on benefit-risk are vital to the structured assessment process across the lifecycle of developing drugs and devices. Learn more here about how to participate effectively in research and policy activities that can enhance patient-centered decision-making about medical products in development, under regulatory review, and on the market.

Featured Items


Publications & Events

BIO Lifecycle Assessment
Lifecycle Approach to FDA’s Structured Benefit-Risk Assessment

Source: Biotechnology Innovation Organization (BIO)

MDIC framework report 2015
Patient Centered Benefit-Risk Project report

Source: Medical Device Innovation Consortium

PPMD report
Putting patients first

Source: Parent Project Muscular Dystrophy

Benefit-risk Metcalf article
Patient input at the FDA: Who, what, why & when?

Source: Campaign for Modern Medicines

Benefit-risk Metcalf article
PDUFA V: Enhancing benefit/risk analysis at the FDA

Source: Campaign for Modern Medicines

Benefit-Risk Metcalf article
Risk/benefit analysis: What, how, and why?

Source: Campaign for Modern Medicines

PhRMA benefit-risk understanding post
Understanding patient perspective critical in benefit-risk assessment

Source: Pharmaceutical Research and Manufacturers of America

FDA Benefit-Risk page
Enhancing benefit-risk assessment in regulatory decision-making

Source: U.S. Food and Drug Administration

PPMD Benefit-Risk report cover
Benefit-risk assessment in rare disorders

Source: Parent Project Muscular Dystrophy

Q and A with Bennett Levitan
Q&A with Bennett Levitan

Source: Medical Device Innovation Consortium

MDIC benefit-risk project
Patient Centered Benefit-Risk Assessment Project

Source: Medical Device Innovation Consortium

PCORI patients in research
Research in action site

Source: Patient-Centered Outcomes Research Institute

PhRMA benefit-risk balance post
Understanding the benefit-risk balance of medicines

Source: Pharmaceutical Research and Manufacturers of America

PhRMA Benefit-Risk statement
PhRMA statement on FDA Benefit-Risk Assessment Plan

Source: Pharmaceutical Research and Manufacturers of America



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