Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry; Extension of the Comment Period
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The Food and Drug Administration (FDA or we) is extending the comment period for the notice announcing the availability of a draft guidance entitled "Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products; Draft Guidance for Industry," that appeared in the Federal Register of July 14, 2023. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments.
Abstract as published in the Federal Register.
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