Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

PDUFA VII: Will Gene Therapy's Rise Influence Talks?

Executive Summary

The Center for Biologics Evaluation and Research may need more fee revenue to add employees to handle the increasing cell and gene therapy workload.

You may also be interested in...



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.

PDUFA VII Talks Begin With Similar Goals For Industry, US FDA

Both sides want enhancements to deal with growth in cell and gene therapy, as well as work on regulatory decision tools and finance issues.

User Fee Renewal Negotiations Beginning This Week

Talks between US FDA and industry to extend the generic drug and prescription drug user fee programs may last into 2021.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM006051

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