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Early Access Programmes / Compassionate Use Programmes: How to effectively deal with the challenges
Published on: Jun 1, 2017
Early access programmes (sometimes also called compassionate use or temporary use authorisation) were set up because of the rapid advances in science and the legitimate expectations of physicians or patients for early access to unauthorised medicinal products prior to marketing authorisation and commercial launch (with the assumption that a favourable risk: benefit exists). This paper discusses the possible pathways to an early access programme.
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