FDA to Host OTP Town Hall on Preparing BLA Submissions for Cell and Gene Therapies

The Food and Drug Administration’s Center for Biologics Evaluation and Research, Office of Therapeutic Products (OTP), will host a virtual town hall June 4 on best practices for preparing biologics license applications (BLAs) for cell and gene therapy products.

During the session, experts from OTP’s Office of Review Management and Regulatory Review will address BLA readiness, including how to request pre-BLA meetings, best practices for preparing submission packages and tools to navigate the application process.

The event will take place from 11 a.m. to 12 p.m. ET and will be streamed publicly; registration is not required. A recording will be made available following the event.

Interested individuals may submit discussion questions via email by May 15. Attendees will also be able to submit questions during the live event.