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The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. The next town hall will focus on the clinicaldevelopment of gene therapy products for rare diseases in February 2023.
Development of the manufacturing process description The development of the MPD is an iterative process. The MPD is best created and controlled by a sponsor, rather than by a contract development and manufacturing organization (CDMO) assigned to perform the process and assaydevelopment.
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