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The Importance of Manufacturing in the Development of Advanced Therapies

‐ Jun 26, 2023 12:15pm

Gene therapy offers tremendous promise for the treatment of both rare and common diseases. Despite initial successes, growth of the field has been slower than predicted. By leveraging characteristics that products have in common whenever possible, by intensely focusing on manufacturing, by maximally employing expedited development pathways, and by fostering international collaboration, FDA hopes to accelerate the pace of bringing advances to the benefit of patients.


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