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

UsernamePublicRestriction

Patient-Focused Drug Development: US FDA 'Needs To Be Brave,' Tell Sponsors What Works Best

Executive Summary

At public workshop, FDA says it will be flexible on clinical outcome assessments but stakeholders want agency to specify no-no's; digital health technology is appropriate to get more accurate endpoints, agency says.

You may also be interested in...



Patient-Focused Drug Development Guidance: Determining When A Clinical Outcome Assessment Is Appropriate

A US FDA draft guidance on selecting and developing fit-for-purpose clinical outcome assessments specifies the evidence that can be provided to support using a COA in a particular context.

Could ICER Outreach To US FDA Lead To Better Cost Effectiveness Analyses?

To aid its value assessments, ICER is interested in helping FDA understand the importance of patient-relevant outcomes and consistent endpoints across trials of drugs for the same disease.

Patient-Focused Drug Development: US FDA’s Guidance Development Effort Passes The Mid-Point

Agency has issued two of four methodological draft guidances required under 21st Century Cures Act and convened workshops on the two documents still to come; industry, patient groups applaud FDA’s initiative but point to gaps in the guidance series, particularly around interactions with the agency on patient experience data and approaches to collecting patient preference information.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS124124

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

Cancel