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美国卫生研究院文献>Orphanet Journal of Rare Diseases
>Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties
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Evidence supporting regulatory-decision making on orphan medicinal products authorisation in Europe: methodological uncertainties
BackgroundTo assess uncertainty in regulatory decision-making for orphan medicinal products (OMP), a summary of the current basis for approval is required; a systematic grouping of medical conditions may be useful in summarizing information and issuing recommendations for practice.
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