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  4. OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023 - 04/25/2023
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Town Hall

Event Title
OTP Town Hall: Gene Therapy Chemistry, Manufacturing, and Controls – April 2023
April 25, 2023

Scheduled
Date:
April 25, 2023
Time:
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 Tuesday, April 25, 2023. Due to high interest from the public in our September 2022 virtual town hall, this event will focus on gene therapy chemistry, manufacturing, and controls. Gene therapy-related research and development continues to grow rapidly, resulting in an increasing number of products being evaluated in late-stage clinical studies in support of product licensure.

What Are 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 (IND) and license applications. For gene therapies and other biologic products, the CMC information in an IND should describe the sponsor’s commitment to perform manufacturing and testing to assure product safety, identity, quality, purity, and strength (including potency). CMC information collected during the course of clinical development is used to support license applications. For more information, see the FDA gene therapy CMC guidance document or view materials from the September 2022 gene therapy CMC town hall event. 

Meeting Logistics

  • Date: Tuesday, April 25, 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 March 24, 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 products or pending guidance documents 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, 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.

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