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

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...



CBER Will Devote More Time To Non-COVID-19 Work Beginning In Six Months

Center for Biologics and Evaluation and Research is to resume normal operations at the beginning of 2023 and will stop prioritizing resources for COVID-19 regulatory work over non-COVID-19 matters.

US FDA’s Overloaded Advanced Therapies Office Eyes Organizational, Communication Changes

Office of Tissues and Advanced Therapies seeks to optimize its organizational structure and adopt more group-level communications, instead of one-on-one interactions with sponsors, to keep up with the massive growth in cell and gene therapies, director Wilson Bryan says.

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.

Related Content

Topics

Latest News
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