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Post# of 700553
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hyperopia

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hyperopia

Re: Poor Man - post# 587272

Thursday, 04/20/2023 9:14:36 PM

Thursday, April 20, 2023 9:14:36 PM

Post# of 700553
Poor Man, the supply chan and logistics for an advanced therapy product are considered a part of the manufacturing process, and are included in the quality (CMC) module of the MAA. Any regulatory updates from last year would need to be updated in the MAA.
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