Posted On: 03/11/2016 2:15:43 PM
Post# of 30034
First, this has nothing to do with us.
Second, you have to have an approved product before you get a voucher.
"Under section 529(a)(2) of the FD&C Act, a priority review voucher is a voucher that FDA issues to the sponsor of a rare pediatric disease product application at the time of the marketing application approval."
Approval of the marketing application is approval of the product for sale (i.e., FDA approval).
It's not like a voucher is coming anytime soon.
Second, you have to have an approved product before you get a voucher.
"Under section 529(a)(2) of the FD&C Act, a priority review voucher is a voucher that FDA issues to the sponsor of a rare pediatric disease product application at the time of the marketing application approval."
Approval of the marketing application is approval of the product for sale (i.e., FDA approval).
It's not like a voucher is coming anytime soon.
Quote:
Damn, I was really hoping they would get the PRV Voucher. It looks like someone else got it today. That would have turned around the company overnight.
www.fda.gov/NewsEvents/Newsroom/PressA...490329.htm
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