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

US FDA Aims To Speed Communications On Cell And Gene Therapy Issues With Q&A Guidance

Executive Summary

Advocates also call for reauthorization negotiations to be open to the public during meeting on the PDUFA VII commitment letter.

You may also be interested in...



BsUFA III Expands Biosimilar Supplement Review Goals To Speed Approvals

Six supplement categories based on submission content will be created with review goals between three and 10 months.

A PDUFA First: Pre-Approval Inspection Notice Goal Will Be Created

Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.

GDUFA III Talks Completed; Fees will Fund Inspection, Complex Generic Improvements

Post-warning letter meetings for manufacturing issues and updates to the complex product meeting process are included in the user fee extension agreement.

Related Content

Topics

UsernamePublicRestriction

Register

PS145012

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