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

Sponsor-FDA Communications In IND Phase Will Get Outside Review

Executive Summary

US FDA seeks White House approval for to contract for interviews with 100 to 150 active commercial IND holders.

You may also be interested in...



Decline In Civil Discourse Harms US FDA's Operations, Woodcock Says

'Polarization of opinions has always been a problem for us and has only been heightened,' CDER chief tells DIA.

Benefit-Risk Frameworks May Be Coming To US FDA Advisory Committees

Structured assessments, which are currently publicly available only for approved products, could help frame questions for panel discussion of specific drugs under review; FDA also exploring ways to make completed frameworks more readily accessible.

US FDA's Benefit/Risk Framework Gets High Marks But Could Be Improved

Agency summaries contained in reviews of novel drugs and biologics are useful and informative but difficult to find, and their use should be expanded to other types of applications, industry sponsors and other external stakeholders say.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS123704

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