Impact of changes in regulatory framework on approval of medicines for rare diseases and applicability to market access policies
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DOI: 10.3389/fmed.2025.1474087
Abstract: The introduction of the Orphan Drug Act in the USA in 1983, followed by adoption of the Orphan Drug Regulation No 141/2000 in the EU in 2000, led to a change in landscape of drug… read more here.
Keywords: changes regulatory; rare diseases; medicines rare; access ... See more keywords