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

CDER Dispute Resolution Data Show Few Wins For Sponsors

Executive Summary

Number of appeals has leveled off in recent years, but odds of sponsors getting all the relief they seek remain low.

You may also be interested in...



US FDA Drugs Center Launches Clinical Trial Innovation Hub With Demonstration Projects

CDER’s Center for Clinical Trial Innovation (C3TI) will support innovative clinical trial approaches designed to improve the quality and efficiency of drug development and regulatory decision-making. The initiative includes demonstration projects on Bayesian analyses, selective safety data collection and point-of-care trials.

Preterm Birth Prevention Studies Need To Look Beyond Makena Endpoints, Experts Say

Gestational age and a binary, neonatal composite endpoint are insufficient to assess outcomes that are important to babies and families, clinicians and researchers say, suggesting development of continuous variables or scales with weighted components and a comparison of outcomes among newborns in gestational age ‘buckets.’

Clinical Trial Diversity Requires Sponsors Work With An Assortment Of Patient Advocates, Community Organizations

US FDA oncology officials are concerned that the entities sponsors are consulting in developing and implementing clinical trial diversity plans are not sufficiently diverse themselves and do not represent patients in underserved communities.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS057141

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