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

US FDA's Patient Affairs Office Is An Office … In Spirit

Executive Summary

Rachel Sherman says agency is creating patient affairs staff, but will not undergo reorganization to create an official office.

You may also be interested in...



Expanded Access: US FDA Told To Increase Regulatory Clarity, Early Interactions With Sponsors

Independent assessment finds positive perceptions of expanded access program but calls on agency to do more to correct manufacturer misperceptions about adverse events and clarify when data from expanded access would support labeling extensions.

Orphan, Combo, Pediatric Products Would See More Influence In Proposed US FDA Reorg

Reorganization also may force change to commissioner succession plan.

US FDA/NORD Partnership Will Further Increase Patient Involvement In Drug Development

Agency's agreement with rare disease advocacy group will facilitate patient meetings with review divisions, as well as enhance communication of safety information.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS121990

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