Regulatory Open Forum

Hi all,

Assumptions made:

1. FDA alignment to seek accelerated approval.
2. Evidence of effectiveness is shown in Ph 3 studies
3. Meet criteria of serious conditions

Is it possible to seek accelerated approval and request priority review for a NDA, at the same time?

Thanks community!

Yes! Priority review is determined after you submit the application, 60 days from receipt date by the FDA.

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GRSAOnline
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Generally, you will have FDA agreement on accelerated approval before submitting your NDA. Then in the NDA application you will state your request for accelerated approval and acceptance of the conditions of such. Priority review is determined by FDA at the time of filing of the NDA and would be generally assumed to granted for a filed NDA with the potential for accelerated approval.

Bottomline, yes, both accelerated approval and Priority review can be requested at the same time!