by
Fajar Dumadi, BSc
Regulatory Program Specialist
ISCT Head Office
ISCT hosted the 20th FDA CTLM on December 8, 2023 with over 45 participants, comprised of representatives from AABB, ASFA, ASTCT, CAP, CBA, FACT, FDA/CBER/OTP/OCTHT/OGT/OCBQ/OCOD, ISCT, NHLBI, NMDP, SITC, USP, WMDA.
Topics Covered Include:
- Cellular and Tissue Material as Raw “Starting” Material for iPSC clinical products and other Cell Banks
- Changing the definition of starting material
- QC Testing for Point of Care (POC) Manufacturing
- Request for Guidance Document Clarifying Which Entities are Required to Register with FDA for Manufacture of Human Stem Cells, HCT/Ps
- Challenges with Moving Cell and Gene Therapies into the Commercial Space for Rare Diseases
Full meeting summary and presentations will be available on January 15, 2024 on the ISCT website.
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