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European regulation on orphan medicinal products: 10 years of experience and future perspectives

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References

2008Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma229 cited
2010Emergence of orphan drugs in the United States: a quantitative assessment of the first 25 years148 cited
2009Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency128 cited

Cited by

2012Rare diseases, orphan drugs, and their regulation in Asia: Current status and future perspectives117 cited
2021Using four decades of FDA orphan drug designations to describe trends in rare disease drug development: substantial growth seen in development of drugs for rare oncologic, neurologic, and pediatric-onset diseases96 cited
2017Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen71 cited
2016References0 cited

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