USA - FDA drafts two guidances on safety testing for cell and gene therapy products
Year: 2024
Type: other
Abstract: The US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) on Tuesday issued two draft guidances related to cell and gene therapy testing: one addresses safety testing products derived of human allogeneic cells expanded for use in cell-based products and the other addresses testing animal- and human-derived materials in the manufacturing of cell and gene therapy and tissue engineered medical products (TEMP). More information on the Regulatory Focus Website.
Source: OpenEdition (OpenEdition)
DOI: 10.58079/12f94
Author: Vroby
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: green
OpenAlex ID: W6974353107
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