FDA releases new final guidance "Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application". This guidance is brief at only 8 pages and is focussed at giving sponsors and manufacturers greater flexibility for CGT products but notes in the Introduction that this guidance is in addition to other guidance already issued:
"FDA has issued several guidances that provide CMC recommendations to sponsors developing CGT products. Sponsors developing CGT products should consider the CMC recommendations in this guidance in addition to those guidances for industry, as applicable. This guidance provides information on when CMC flexibilities may be appropriate for the development of CGT products and does not comprehensively address the CMC information and data necessary to support CGT product licensure under section 351 of the Public Health Service Act (42 U.S.C.262)."
#fda #CMCFlexibility #GCT
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/chemistry-manufacturing-and-controls-flexibilities-developing-human-cellular-and-gene-therapy
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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