Regulatory Initiatives

ISCT-AABB GTP Interpretative Tool

A New Collaborative Effort to Facilitate Regulatory Compliance 

ISCT and AABB are pleased to offer our members access to the jointly created ISCT-AABB GTP Interpretative Tool to help educate the cell therapy community regarding the interpretation of GTP requirements and how best to prepare for FDA inspections of establishments that manufacture HCT/Ps. 

Available to ISCT and AABB Members Only.

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ISCT Cell and Gene Therapy Regulatory Report

A collaborative report was created in partnership with Citeline (as data partner). This report will cover a global overview of the cell and gene therapy regulatory landscape, including pipeline, late-stage (Phase III and pre-registration), and approved products. This report will also highlight changes in key global legislation/framework as well as international standards.

Open access – Report Available Soon!

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