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

Sponsors Still Not Racing To Schedule In-Person Meetings With US FDA

Executive Summary

The vast majority of meeting requests eligible for the in-person/virtual format were not requested as such, according to Center for Drug Evaluation and Research data.

You may also be interested in...



How Can FDA Advance Cell Therapy R&D? Issue Guidance in ‘Real Time,’ Encourage Collaboration With Industry, CBER’s Marks Says

CBER will take a page out of the drug center’s book and start issuing shorter guidances more quickly; sponsors should also be on the lookout for an RIF on ways to collaborate with agency.

Supplemental Filings: Back To US FDA’s Conference Center, What Marks Wants In A Gene Therapy Director, And More

Short stories about how US FDA’s conference center changed since COVID-19 forced the end of in-person public events, what the agency did to officially close the books on Makena, and more.

US FDA Holds First Hybrid Meeting With Industry

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.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS148984

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