Navigating through orphan medicinal product regulations in EU and US – Similarities and differences

Navigating through orphan medicinal product regulations in EU and US – Similarities and differences. Jyoti Tiwari, Regulatory Toxicology and Pharmacology, Volume 71, Issue 1, February 2015, Pages 63-67, ISSN 0273-2300, http://dx.doi.org/10.1016/j.yrtph.2014.11.006.

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