FDA Looking To Patient Advocates To Answer Benefit-Risk Questions
This article was originally published in RPM Report
Executive Summary
FDA’s clinical review teams are starting to approve novel drugs and biologics using a new structured benefit-risk framework developed under PDUFA V. Those assessments ask reviewers to think more broadly about the disease and how a new treatment might fit into the current treatment model. But many reviewers don’t have that information. And that, FDA says, is where patient advocates come in.
You may also be interested in...
FDA Breast Cancer Patient Meeting Likely To Examine Differences Between Early-Stage and Metastatic Experiences
In April, FDA’s patient focused drug development initiative will look at one of the most emotionally and politically fraught areas of advocacy: breast cancer. Here’s a look at what the agency is likely to hear.
Provectus Breakthrough Denial Is Symptom Of a Different Breakthrough at FDA
Provectus Pharmaceuticals raised a few eyebrows by raising the curtain on FDA’s rejection of its Breakthrough status application for its malignant melanoma drug. By making the letter public, the company shed light on the broader issue of how seriously FDA is taking symptom improvement as a component of clinical meaningfulness in some cancers.
FDA Needs Formal Mechanism To Integrate Patient Input, Groups Say
Although FDA says its drug reviewers are benefiting from the patient-focused drug development meetings under PDUFA V, stakeholders say a formal methodology is needed to incorporate patient input into the benefit-risk framework and drug review process.