Therapeutic innovation & regulatory science
An Industry Perspective on Compassionate Use in Europe: A Call for Change.
Philipp Schlatter, Nina Heiss, Pedro Franco, Annie O'Keefe Martin, Susan Robson, Ramona Reichenbach
Published: 202510.1007/s43441-025-00902-y
Abstract
BACKGROUND: Options for patients to receive unauthorised medicines through compassionate use (CU) in Europe vary greatly. There are two CU pathways: cohort programmes, regulated uniformly by the Regulation across EU member states, and individual pati…
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