Considering that we already have FDA approval and going by this statement on their web page, one would think that we should gain approval on the first pass being 3-5 Nov. - not long to wait!
Because rare diseases are a global issue, the Agency (EMA) works closely with its international partners on the designation and assessment of orphan medicines, in particular:
- the United States Food and Drug Administration (FDA), sharing information on orphan medicines under their confidentiality arrangement. The two authorities have also developed common procedures for applying for orphan designation and for submitting annual reports on the status of development of designated orphan medicines.
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