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Re: jackpam post# 27576

Sunday, 11/02/2014 10:40:28 AM

Sunday, November 02, 2014 10:40:28 AM

Post# of 144814
DIRECT FROM THE FDA...

What happens after submission?

You will be sent a letter acknowledging receipt of the application.
Reviewed by reviewer ? designation Team Leader ?OOPD director.

Expect <90 days to decision.

A negative decision can always be readdressed.

Roughly 60-70% of applications result in
granting orphan drug designation status.



EXPECT LESS THAN 90 DAYS TO DECISION

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