Tongted Das, PhD Monash Health Australia Jessica Sue, BSc, MHSM Junior Associate Editor, ISCT Telegraft Sydney Cord Blood Bank Sydney Children's Hospital Network Australia ISCT Representation in Recent Regulatory Work (Australia) The ISCT committee participated in the following...
Fajar Dumadi, BSc ISCT Canada Committee for Advanced Therapies (CAT) Agendas for recent meetings Agenda for the meeting on 16-18 July 2025 https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-16-18-july-2025 en.pdf Agenda for the meeting on 10-12 September...
Kasey Kime, MBA BioOra New Zealand Giulia Giunti, PhD BioOra New Zealand AOTEAROA – NEW ZEALAND Medsafe Medsafe published their performance statistics for the evaluation of new and changed medicines between 1 July 2024 and 30 June 2025 (1). Ministry of Business,...
Fajar Dumadi, BSc International Society for Cell & Gene Therapy (ISCT) Canada This report provides links to the latest updates from European-based regulatory agencies, including CAT quarterly highlights and approved ATMPs, warning about unregulated ATMPs in the EU, EMA...
Aisha Khan, PhD, MBA Executive Director, Clinical Research Cellular Manufacturing Program Interdisciplinary Stem Cell, University of Miami Miller School of Medicine The Resignation of Dr. Peter Marks: A Critical Loss for Science-Based Oversight and...
Paula Stoddart Clinical Manager, Miltenyi Biotec Australia Jessica Sue Quality Manager, Sydney Cord Blood Bank, Sydney Children’s Hospitals Network AUSTRALIAN AND NEW ZEALAND REGULATORY UPDATES AOTEAROA – NEW ZEALAND Medsafe On 31 st March 2025 the...
Author: María de Jesús Medina Arellano, PhD Institute of Legal Research, UNAM México Editor: Lilia Carolina Leon-Moreno, PhD Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco (CIATEJ) México Introduction Cell...
Aisha Khan, PhD, MBA University of Miami Miller School of Medicine United States FDA Releases Draft Guidance on AI Use in Regulatory Submissions In February 2025, the U.S. Food and Drug Administration (FDA) issued a draft guidance titled Considerations for the Use...
Author: Fajar Dumadi, BSc International Society for Cell & Gene Therapy (ISCT) Canada Committee of Advance Therapy (CAT) Minutes and Agendas for recent meetings · Minutes of the CAT meeting on 22-24 January 2025 https://www.ema...
Co-Authors: Gabrielle O’Sullivan, PhD, MPH(Hons) Royal Prince Alfred Hospital Australia Paula Stoddart Miltenyi Biotec Australia AUSTRALIAN AND NEW ZEALAND REGULATORY UPDATES AOTEAROA – NEW ZEALAND New Zealand Ministry of Health ...