OTCPK:ARLZQ - Post by User
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PoorOpinionon Apr 20, 2016 8:45am
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More news out today
More news out todayI found a link with a simple explanation of the pdufa date if people were wondering what it meant
https://www.eyeonfda.com/eye_on_fda/2010/07/what-is-pdufa.html
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What is a PDUFA date? The new system established set time periods for the FDA to review a new application, usually set at a 10-month period. If a drug, however, gets a priority review designation, then the review time will be set at 6 months. (A priority review is given to drugs that offer a significant new breakthrough in treatment, or offer a treatment where none or few exist, and can be given for a drug which treats a serious condition as well as those that treat less serious conditions). The timing for the clock to tick begins when the company submits the new drug application to the FDA. The date is a target for FDA, but the agency can, and many times does, announce a decision prior to the PDUFA date. "