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

FDA Piloting Oncology Supplement Review Using Only Data Summaries

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Advantages could be shorter review times and expanded labels, but there are concerns about no global regulator having access to full patient-level data.

You may also be interested in...



'Progressive Approval' Coming? US FDA Considers Accelerated Approval Without Surrogates

Commissioner Gottlieb tells Congress that concept could be used for some clinical endpoints when a large benefit is seen in a small trial, which could benefit rare disease drug development.

Avastin Ovarian Cancer Approval Brings Some Clarity On PFS Endpoint

New claim for platinum-resistant recurrent disease based on a median 3.4-month improvement in progression-free survival – with favorable trends in overall survival, overall response rate and duration of response – confirms agency’s willingness to entertain a progression endpoint in this tumor type.

FDA/EU Mutual Reliance For GMP Inspections Moving Forward

Both sides may agree to overlook “areas of divergence” if they don’t appear significant.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS005630

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