Gene Therapy Experts Discuss Regulatory and Manufacturing Challenges with FDA Leadership

Gene therapy experts and advocates outlined several pressing challenges facing the field during a regulatory forum held Thursday, where they engaged with leadership from the U.S. Food and Drug Administration (FDA). The discussion highlighted concerns about regulatory hurdles, manufacturing complexities, and financial sustainability within the rapidly evolving sector.

During the meeting, FDA officials listened to detailed accounts of obstacles that researchers and companies encounter as they work to develop gene therapies. Participants emphasized issues such as navigating intricate approval processes, scaling up production while maintaining quality standards, and addressing high costs associated with development. The forum provided an opportunity for stakeholders to share their perspectives directly with regulators in hopes of fostering collaboration to address these challenges.

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Source: GO-AI-ne1

Date: June 6, 2025

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Author

Mark Chiang