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Re: MADDSTACKER post# 455

Wednesday, 07/19/2017 4:42:12 PM

Wednesday, July 19, 2017 4:42:12 PM

Post# of 837
https://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm

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.