FDA Hosts Town Hall on Gene Therapy Manufacturing Regulations

ROCKVILLE, Md. — The FDA’s Center for Biologics Evaluation and Research (CBER) hosted a virtual town hall on October 22, 2025, focusing on gene therapy manufacturing regulations. This event featured experts from the Office of Therapeutic Products (OTP) and the Office of Compliance and Biologics Quality’s Division of Manufacturing and Product Quality (DMPQ).

The town hall aimed to address questions about Chemistry, Manufacturing, and Controls (CMC) and facility readiness for Biologics License Applications (BLA) and post-licensure changes. Facility inspections are vital for the BLA review process and must occur for a license to be granted, according to FDA guidelines.

“Facility readiness and compliance are critical components of gene therapy development,” said an FDA spokesperson during the town hall. “We want to ensure that manufacturers are well-prepared for inspections.”

Changes to the product or process often occur post-licensure. The FDA emphasizes that a well-designed change management process is essential in these situations. “An effective change management system helps assess risks to product quality,” the spokesperson added.

The OTP developed the town hall series to engage with researchers and product developers on regulatory topics. The events follow a question-and-answer format to share vital information and promote discussions about drug development.

For more information on future town halls and FDA updates, interested parties can sign up for newsletters through the FDA’s CBER website.