December 8, 2017

EMA encourages Sponsors to consult before applying for orphan designation as the evaluation of the application takes min. 90 days and missing documents can not be added at this time. Consultations are free of charge and usually take the form of teleconferences. At leas...

December 4, 2017

Rare diseases affect only or as much as 6 - 8% of humanity. They are very rare, but they do exist and people suffer from them. The difficulty of therapy lies in the access to medicines, the price of their preparation and their low sales, which gives a small profit to p...

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