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

Clinical Trial Dropouts, Missing Data Get FDA Attention At GSK Anoro Ellipta Review

Executive Summary

More than a year after hints of forthcoming guidance on missing data, agency looks toward future where sponsors do more to retain patients and follow up on those that leave clinical trials.

You may also be interested in...



Draft Guidances For 2013 Will Grapple With Biosimilars, Track and Trace, Compounding

FDA’s Center for Drug Evaluation and Research plans to publish more than 50 new and revised draft guidances this calendar year.

FDA Panel Looks Beyond Xarelto’s Missing Data Problems To Broader Reforms

Despite the agency’s decision to limit discussion about missing data to the ATLAS pivotal trial of rivaroxaban, Cardio-Renal advisory committee members suggested reforms that sponsors should consider to prevent the kinds of problems seen in ATLAS.

FDA Advice On Missing Data May Be To Avoid Missing It In The First Place

FDA officials respond to the recommendations of a National Research Council Panel on handling missing data in clinical trials, giving early indications of how FDA could be viewing a forthcoming guidance on the issue.

Topics

Related Companies

UsernamePublicRestriction

Register

LL1134409

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