Gene Therapy Forum Highlights Regulatory, Manufacturing, and Financial Challenges with FDA

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 the financial sustainability of developing gene therapies. FDA officials listened to these concerns as part of an ongoing dialogue aimed at addressing issues within this rapidly evolving sector.

The forum provided a platform for stakeholders to voice apprehensions about the current state of gene therapy development. Participants emphasized difficulties in navigating regulatory pathways, particularly for rare diseases where patient populations are small. They also pointed to obstacles in scaling up manufacturing processes to meet clinical and commercial demands. Financial pressures were another key topic, with advocates noting that high costs associated with research, development, and production could hinder broader access to these innovative treatments. FDA representatives acknowledged these challenges while engaging in discussions on potential solutions and strategies to support advancements in the field.

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Source: GO-AI-ne1

Date: June 6, 2025

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Author

Mark Chiang