News Focus
News Focus
Followers 22
Posts 3351
Boards Moderated 0
Alias Born 01/17/2013

Re: Doc_John post# 9348

Sunday, 07/28/2013 10:07:08 PM

Sunday, July 28, 2013 10:07:08 PM

Post# of 114001
Fast Track designation must be requested by the drug company. The request can be initiated at any time during the drug development process. FDA will review the request and make a decision within sixty days based on whether the drug fills an unmet medical need in a serious condition.

Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

When SBFM GETS THERE I SEE $$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$$
IMHO