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  4. OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs - 09/05/2024
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Town Hall | Virtual

Event Title
OTP Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs
September 5, 2024

Date:
September 5, 2024

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) hosted a virtual town hall on Thursday, September 5, 2024. In this event, experts from OTP’s Office of Cellular Therapy and Human Tissue CMC answered questions regarding development and readiness of chemistry, manufacturing, and controls (CMC) data and information for late-stage investigational new drug applications (INDs) – INDs intended to collect primary evidence of effectiveness to support a marketing application for cell therapy and tissue-engineered products.

Focus for this Town Hall: Cell Therapy CMC Readiness for Late-Stage INDs

The FDA requires sponsors to provide CMC information as part of an investigational new drug, biologics license, and new drug applications. For cell therapy and tissue-engineered products, the CMC information should describe the sponsor’s commitment to assure product safety, identity, quality, purity, and strength (including potency). The focus of this virtual town hall was to answer questions related to CMC data and information needed to support late-stage INDs for cell therapy and tissue-engineered products. For more information, please view materials from previous town halls on cell therapy CMC.

View the September 2024 recording for the OTP Town Hall on Cell Therapy CMC Readiness for Late-Stage INDs.

About the OTP Town Hall Series

OTP launched its virtual town hall series to engage with product developers and researchers 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 advance drug development. Learn more about OTP and view recordings from our previous town hall events.

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