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) is hosting its next virtual town hall on Thursday, June 8, 2023. Due to high interest from the public, this event will focus on cell therapy chemistry, manufacturing, and controls (CMC), including tissue-engineered medical products regulated by OTP, and will be a continuation of the December 2022 virtual town hall. Experts from the Office of Cellular Therapy & Human Tissue CMC will be on-hand to answer questions.
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.
- Date: Thursday, June 8, 2023
- Time: 11:30 a.m.–1:00 p.m. ET
- Location: The webinar will be held via Zoom.
- Registration: Registration is required. Please register for the event now.
Submit a Question
Questions can be submitted during the registration process. Please submit questions by May 12, 2023. Attendees will also be able to submit questions during the live event.
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 OTP Town Hall Series
OTP 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.
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