Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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

UsernamePublicRestriction
UsernamePublicRestriction

FDA Needs Formal Mechanism To Integrate Patient Input, Groups Say

Executive Summary

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.

You may also be interested in...



Quality-Of-Life, Emotional Well-Being Becoming Highly Utilized PROs In Diabetes Trials

Industry mostly using the patient-reported outcomes as exploratory endpoints.

You Just Have To Wait: FDA Can't Hurry PDUFA VI Guidances

In response to stakeholder concern about multi-year schedule for patient-input guidance development, FDA says it only has a few experts and has to balance their time.

FDA Looking To Patient Advocates To Answer Benefit-Risk Questions

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.

Related Content

Topics

UsernamePublicRestriction

Register

ID1132046

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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

Cancel