habe vorgestern eine Mail ans FDA geschrieben
Dear Sirs or Mesdames,
I have a question referring to the orphan drug. Is it possible that 2 companies will get the approval of an orphan drug for same disease almost at the same time, if it isn't so which are the factors it depends on? Thanks in advance. Kind regards
Antwort: Dear Stephan,
Thank you for writing to the Division of Drug Information, in the FDA's Center for Drug Evaluation and Research (CDER).
Your email has been forwarded for internal consultation. If you do not receive a direct response from FDA within 20 business days, please feel free to follow up with me.
Kind regards,
SV Division of Drug Information Center for Drug Evaluation and Research Food and Drug Administration
Also in spätestens 20 business Days, weiß ich bescheid ob wir eine chance auf den Ophan drug status haben :D!
IMHO |