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midastouch017

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midastouch017

Re: Fmello post# 3181

Monday, 08/15/2022 9:34:44 AM

Monday, August 15, 2022 9:34:44 AM

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How long does it take the FDA to review a BLA?
The timelines for NMEs and BLAs that fall under PDUFA V's “Program” Review Model are 10-months for standard applications and 6-months for priority reviews from the 60-day filing date (or 12 months and 8 months respectively from the date of submission of the application).
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