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

CBER Designing Triage System For Gene Therapy Submissions In Lieu Of ‘First In, First Out’ System

Executive Summary

Ideally, the system will prevent some cell and gene therapy programs from slowing, CBER Director Peter Marks says.

You may also be interested in...



PDUFA VII Commitment Letter Outlines Real-Time Review Expansion, Hiring Goals

Allergenic extract products, previously excluded, also will become part of the user fee program beginning in FY 2023.

US FDA Lowers FY '22 PDUFA Fees Due to Hiring, Attrition Concerns

The agency reissued the user fee notice, saying fewer dollars were needed for new staff.

The COVID Boom: CBER Receives More INDs in One Quarter Than The Previous 30 Combined

Bubble was short-lived, but still could create workload problems for the US FDA as it navigates the end of the coronavirus pandemic.

Related Content

Topics

UsernamePublicRestriction

Register

PS145208

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