CBER Town Hall to Focus on Best Practices for Regulatory Interactions With OTP

The FDA’s Center for Biologics Evaluation and Research (CBER) Office of Therapeutic Products (OTP) announced a virtual town hall on Dec. 12 to provide guidance for developers of cell and gene therapies. Staff from OTP’s Office of Review Management & Regulatory Review (ORMRR) will lead the session, which will focus on the best practices for regulatory interactions with OTP throughout product development.

The town hall will cover formal interactions between OTP and developers of advanced therapies. During these interactions, ORMRR experts serve as primary contacts, helping developers navigate the requirements for investigational new drug (IND) applications and biologics license applications (BLA). Attendees will learn about key considerations for requesting and preparing for meetings and tips for productive engagement across the development lifecycle.

The event will take place from 11 a.m. to 12:30 p.m. ET via Zoom. Registration is required.