We were granted this rolling review process to rev
Post# of 153880
(Total Views: 593)
Posted On: 07/15/2020 12:16:59 PM
Re: Goosebumps #43092
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We were granted this rolling review process to review our BLA as an on going review for the duration of our application process. That hasn’t stopped.
Quote:Source Link: https://www.fda.gov/media/78941/download
I don’t believe they are not getting ahead of the work load of the complete review just because we lacked a couple small items they requested.
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A refusal-to-file decision ends the review process . The applicant’s options are to resubmit the NDA/BLA with the deficiencies addressed (the resubmission is considered an original new application) or to request that the NDA/BLA be filed over protest. PDUFA V “Program” applications that are subsequently filed over protest are removed from “The Program” and become subject to the standard 6- or 10- month review clock, as applicable. The applicant must be notified of a refusal-to-file decision (via RTF letter) within 60 days after the original receipt date of the application.
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