17 May 2022 - The US FDA's top biologics regulator said the use of a “playbook” or platform approach for developing multiple cell and gene therapy products and a globally harmonised template would facilitate the development of such products at a 17 May meeting of the American Society of Gene and Cell Therapy.

Peter Marks, the director of the FDA’s Center for Biologics Evaluation and Research and Ana Hidalgo-Simon, head of advanced therapies at the EMA, also agreed that manufacturing and reimbursement challenges are impeding the development of these products.

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