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

Real-World Evidence: Efficacy Assessments Await FDA Clarity, Pilot Projects

Executive Summary

Greater development and use of real-world evidence, such as pragmatic clinical trials and observational studies, to support regulatory decisions on drug efficacy are limited by regulatory, technical and practical hurdles, stakeholders say.

You may also be interested in...



US FDA Is Hesitant About Using Observational Studies In Real-World Evidence Framework

Agency plans guidance on whether observational studies can provide real-world evidence to support regulatory decisions about drug effectiveness; however, RWE framework includes critical questions about retrospective studies, and reflects agency concerns about transparency.

Duke's McClellan: Changing Drug Development Policy From Outside FDA

In an interview, Margolis Center for Health Policy's Mark McClellan and Gregory Daniel talk about their recent move from Brookings to Duke, the breadth and impact of their work with FDA on drug development issues, and opportunities for potential future collaborations under PDUFA VI.

PDUFA VI: Breakthrough Issues Among FDA Priorities

Agency and industry also decide to drop research into using social media to enhance post-market safety monitoring.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS057508

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