EMA welcomes the political agreement reached by the European Commission, the European Parliament and the Council of the European Union on the reform of the EU pharmaceutical legislation, which will mark the most significant reform of the regulatory framework in the EU in over two decades. The...
Adam Lee, MS Thermo Fisher Scientific United States Kevin Bosse, PhD Nationwide Children’s Hospital United States A Look at the FDA's New Plausible Mechanism Pathway for Bespoke Therapies Top FDA officials, Vinay Prasad and Martin Makary, authored an article in the New England...
Fajar Dumadi, BSc ISCT Canada Committee for Advanced Therapies (CAT) Agendas for recent meetings Agenda for CAT workshop on gene editing on 16 September 2025 https://www.ema.europa.eu/en/documents/agenda/agenda-committee-advanced-therapies-cat-workshop-gene-editing en.pdf ...
Dr. Vorapin Chinchalongporn, PhD SC21 Bio-Pharma Laboratories Thailand Dr. Tongted Das, PhD Monash Health Australia Adam Lee, MS Thermo Fisher Scientific United States The 2025 Global Regulatory Perspectives (GRP), a flagship element of the ISCT annual meeting program since 2009 was held...
Mikey Creane, BSc, MSc, PhD. Ethics of Cell and Gene Therapy Committee, ISCT Ireland An ISCT Ethics of Cell & Gene Therapy Committee Write-Up on Roundtable Session: "Is Germline Editing Feasible and Should it be Permissible?" At the ISCT 2025 Annual Meeting in New Orleans the...
Adam Lee Thermo Fisher Scientific United States A High-Level Overview of Drug Policies in the House Appropriations Bill The New House appropriations report was released, which provides important directives to the FDA. Although no new regulation has been enacted, the bill outlines...
Lilia Carolina Leon-Moreno, PhD Postdoctoral Researcher Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco (CIATEJ) México María de Jesús Medina Arellano, PhD Institute of Legal Research, UNAM México Andrés Gómez De León, MD Associate...
Contributor(s): Fajar Dumadi, BSc International Society for Cell & Gene Therapy (ISCT) Canada Committee for Advanced Therapies (CAT) Agendas for recent meetings Agenda for the meeting on 14-16 May 2025 https://www.ema.europa.eu/en/documents/agenda/agenda-cat-meeting-14...
A summary of the guest presentation at the ISCT 3rd Annual Global Regulators Summit (6th May 2025, Ernest N. Morial Convention Center, New Orleans, USA) by Professor Henry (Hank) Greely, Director, Center for Law and the Biosciences, at Stanford University. Rapporteur: Patrick Foong, PhD...
Contributor: Fajar Dumadi, BSc ISCT Canada The Human Medicines Regulations 2012 (“HMR 2012”) have been amended to take account of the manufacture of a point of care (POC) medicinal product (this includes home-base manufacture) and modular manufactured (MM) medicinal product (this includes...