- September 29, 2022
- 11:30 AM - 12:30 PM ET
The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) hosted a virtual town hall to answer stakeholder questions related to gene therapy chemistry, manufacturing, and controls. This event was the first in a series to answer questions from stakeholders about a variety of topics on which OTAT has regulatory oversight.
Focus For The Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls
The FDA requires sponsors to provide information about chemistry, manufacturing, and controls (CMC) as part of investigational new drug, biologics license, and new drug applications. For gene therapies and other biologic products, the CMC information should describe the sponsor's commitment to perform manufacturing and testing to assure product safety, identity, quality, purity, and strength (including potency). Please see this FDA guidance document for more information about CMC data to support gene therapy product applications. In this town hall, subject matter experts from OTAT’s Division of Cell and Gene Therapy will answer questions related to CMC for gene therapy product development.
Submit a Question
This event has concluded. To see a list of future OTAT events, please visit the events calendar.
Please note, the FDA is not able to comment on or answer questions regarding specific investigational products or drug applications during the town hall. Further, questions considered inappropriate or out of scope for the event will not be addressed.
About the OTAT Town Hall Series
OTAT is launching the virtual town hall series to engage with product development stakeholders and discuss topics related to OTAT-regulated products. The town halls have a question-and-answer format with the goal of providing regulatory information to stakeholders to advance drug development. Learn more about OTAT and view our available resources.
|CBER OTAT Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls Transcript||pdf (370.92 KB)|