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

COVID-19’s Damage To Gene Therapy Development May Last Years

Executive Summary

US FDA's Peter Marks says the field is robust, but hedges on approval predictions for the coming years because of pandemic’s effect.

You may also be interested in...



PDUFA VII Communications: Earlier PMR Talks, Formal Meeting Additions

Sponsors will receive additional agency interactions through the formal meeting process, as well as an option to ask clarifying questions later.

PDUFA VII Negotiations Completed, Commitment Letter Ratification Ongoing

The US FDA, HHS and White House, as well as industry groups, now must sign off on the document.

CBER Proposes Increasing Cell, Gene Therapy Staff In PDUFA VII

'Indirect and direct review roles' would be added with user fee funds after the PDUFA program is reauthorized.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS144476

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