Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products JULY 2023 (Submit Comments by 11/13/2023)

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/manufacturing-changes-and-comparability-human-cellular-and-gene-therapy-products New draft guidance on manufacturing changes and comparability for human cellular and #GeneTherapy products. Listen to this recorded webinar for a high-level overview and submit comments to the docket by November 13, 2023: