Clinical Pharmacology

New clinical pharmacology study findings have been reported from University of Utrecht

Published in Pharma Law Weekly, May 13th, 2008

" To encourage the development of drugs for rare diseases, orphan drug legislation has been introduced in the USA (1983) and in the EU (2000). Recent literature discusses factors that may influence the development of new orphan medicinal products in the EU," scientists in Netherlands report.

"This study aims to identify predictors for successful marketing authorisation of potential orphan drugs in the EU. A comparison between randomly selected authorised and a matched sample of not-yet-authorised orphan drug designations has been performed. Determinants in the study included characteristics of the indication, of the product and of the sponsor. Data were collected from...

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Source: Pharma Law Weekly (2008-05-13)

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