- Date:
- September 5, 2024
- Time:
- 11:00 AM - 12:30 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, September 5, 2024. In this event, experts from OTP’s Office of Cellular Therapy and Human Tissue CMC will answer 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 is 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.
Meeting Logistics
- Date: Thursday, September 5, 2024
- Time: 11:00 a.m. to 12:30 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 registration. Please submit questions by July 31, 2024. 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is not able to comment on or answer questions regarding specific investigational products, biologics applications, or draft guidance documents during the town hall.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 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.
Stay Connected
Sign up for the CBER listserv or follow us on social media to stay up to date on all FDA CBER news and events.
