Guidance: Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products

TitleGuidance: Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
ToC Doc Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
Docket Number2023-18235
Type Notice
Subject Guidance:
Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products
Publication Date2023-08-24
Last Updated Date 2023-08-23 08:15:11 -0400
Last Public Inspection2023-08-23
Filed At2023-08-23T08:45:00.000-04:00
PDF 2023-18235_PI.pdf (104310 bytes)
Download TXT / HTML / JSON
Number of Pages 4
Filing Typeregular
AgenciesFood and Drug Administration

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