Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By


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.

Related Content


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts