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 Holds First Hybrid Meeting With Industry

Executive Summary

A Type A meeting was held in-person with a virtual contingent, the FDA clarified to the Pink Sheet. Several other meeting requests received were eligible, but did not seek an in-person session.

You may also be interested in...



Requests For In-Person Formal Meetings With US FDA Increasing, But Will They Ever Dominate Again?

FDA data suggests sponsors still seem enamored with virtual meetings, even as the FDA expands the sessions eligible for in-person attendance.

US FDA’s No Recording Meetings Rule Already Appears Flexible

At least one sponsor has been recording meetings for several years, suggesting others could receive permission, but the decision comes with risks as well as benefits. As the agency again expands options for in-person meetings, sponsors may want to reflect on what works best for them.

US FDA’s No Recording Meetings Rule Already Appears Flexible

At least one sponsor has been recording meetings for several years, suggesting others could receive permission, but the decision comes with risks as well as benefits. As the agency again expands options for in-person meetings, sponsors may want to reflect on what works best for them.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS147971

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