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  4. OTP Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – June 2023 - 06/08/2023
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Town Hall | Virtual

Event Title
OTP Town Hall: Cell Therapy Chemistry, Manufacturing, and Controls – June 2023
June 8, 2023

June 8, 2023
11:30 AM - 1:00 PM ET

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual town hall on Thursday, June 8, 2023. The event focused on cell therapy chemistry, manufacturing, and controls (CMC), including tissue-engineered medical products regulated by OTP.

View the June 2023 recording for the OTP Town Hall on Cell Therapy CMC.

Focus for This Town Hall: What Are Chemistry, Manufacturing, and Controls for Cell Therapy and Tissue-Engineered Medical Products?

The FDA requires sponsors to provide CMC information as part of an investigational new drug application. The CMC information should describe product manufacturing and testing to ensure safety, identity, quality, purity, and strength (including potency) of the investigational product. Please see this FDA guidance document or view materials from the December 2022 cell therapy CMC town hall event for more information.

About the OTP Town Hall Series

OTP, formerly OTAT, launched its virtual town hall series to engage with product development stakeholders and discuss topics related to OTP-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 OTP and view recordings from our previous town hall events.

View previous OTP Town Halls  

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