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  4. OTP Town Hall: Best Practices for Regulatory Interactions with OTP - 12/12/2024
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Town Hall | Virtual

Event Title
OTP Town Hall: Best Practices for Regulatory Interactions with OTP
December 12, 2024

Date:
December 12, 2024
Time:
11:00 a.m. - 12:30 p.m. ET

The FDA’s Center for Biologics Evaluation and Research (CBER), Office of Therapeutic Products (OTP) hosted this virtual town hall on December 12, 2024. In this event, experts from OTP’s Office of Review Management & Regulatory Review (ORMRR) answered questions regarding best practices for interacting with OTP.

Focus for This Town Hall: Best Practices for Regulatory Interactions with OTP

Developers of advanced therapies, such as cell and gene therapy products, have multiple opportunities to interact with OTP throughout product development. Formal meetings follow established processes and timelines for requesting, scheduling, preparation, conduct, and documentation. These processes and timelines are defined in FDA regulations, guidance documents, and standard operating procedures.  

Staff members in ORMRR are important points of contact for entities developing advanced therapies and provide expertise for productive and efficient interactions with OTP. This town hall answers questions from developers of biological products regulated by OTP under the IND/BLA pathway regarding best practices for productive interactions with OTP throughout the product development lifecycle.

View the December 2024 recording for the OTP Town Hall on Best Practices for Regulatory Interactions with OTP.

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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Event Materials

Title File Type/Size
December 2024 FDA CBER OTP Town Hall Transcript pdf (395.30 KB)
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