Posted On: 02/06/2016 1:26:04 PM
Post# of 30034
The voucher is issued when the new drug application is approved (when the drug is approved) which would be years from now:
"a sponsor who receives an approval of a new drug application (NDA) or biologics license application (BLA) for a rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain expedited FDA review for any subsequent marketing application. "
They may very well receive the RPDD (designation) in the near future, but not the actual voucher. It seems there are a lot of people on line who keep thinking they are close to getting the voucher but they are not- it's only the designation that they would receive at this stage.
"a sponsor who receives an approval of a new drug application (NDA) or biologics license application (BLA) for a rare pediatric disease may be eligible for a voucher, which can be redeemed to obtain expedited FDA review for any subsequent marketing application. "
They may very well receive the RPDD (designation) in the near future, but not the actual voucher. It seems there are a lot of people on line who keep thinking they are close to getting the voucher but they are not- it's only the designation that they would receive at this stage.
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