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


Guidance on CMC elements for somatic cell therapy products

This article was originally published in The Gold Sheet

Executive Summary

FDA issued a guidance on CMC information for human somatic cell therapy INDs on April 10. It replaces an August 2003 draft. The review instructions and template described in the guidance are designed to help FDA reviewers in evaluating INDs for these products. The guidance contains detailed requirements for characterizing master cell banks, working cell banks and reagents. It also states that manufacturers should include a detailed description of all procedures use during the collection, production and purification of cellular therapy products



Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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