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Defining Satisfactory Methods of Treatment in Rare Diseases When Evaluating Significant Benefit-The EU Regulator's

Maria E Sheean1, Frauke Naumann-Winter2,3, Giuseppe Capovilla2,4,5

  • 1European Medicines Agency, Amsterdam, Netherlands.

Frontiers in Medicine
|September 13, 2021
PubMed

Keywords:
committee for orphan medicinal productsorphan designationorphan regulationsatisfactory methods of treatmentsignificant benefit

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