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

Failed Pediatric Study Data To Get FDA Review At Patient Meeting

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency officials plan discussion of how analysis of failed pediatric clinical trial data can improve future trials during annual patient network meeting.

You may also be interested in...



J&J’s Clinical Data Disclosure Strategy Focuses On Collaboration With Yale University Group

In what appears to be the most expansive policy to date on release of clinical trial data, J&J will use an existing outside group and will share full clinical study reports and patient-level data regardless of when the studies were conducted.

“Patient Voice” Report Puts Chronic Fatigue Symptoms, Treatments In Benefit/Risk Framework

FDA report on CFS/myalgic encephalomyelitis is first of its kind from the patient-focused drug development initiative under PDUFA V. Incorporating comments from hundreds of patients and caregivers into a structured framework shows how the input may support a benefit/risk assessment for new products.

FDA To Be More Vigilant About Proposed Clinical Trial Exclusions

FDA’s Bob Temple says “document” being drafted will instruct reviewers to pay more attention during sponsor meetings and eliminate unnecessary exclusions from protocols.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS077443

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