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Re: Ubertino post# 13459

Wednesday, 06/22/2016 6:55:46 PM

Wednesday, June 22, 2016 6:55:46 PM

Post# of 40490
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.

Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients.

http://www.fda.gov/ForPatients/Approvals/Fast/ucm405399.htm

Let's get moving on this!

Nero fiddled while Rome burned!!

Enough with fiddling.

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