"Earlier than expected: FDA early approvals and an analysis of their frequency, importance and targeted products"

FDA’s PDUFA (Prescription Drug User Fee Act) sets precise goals regarding the duration of review of NDAs and BLAs, but in some cases, for example in diseases with higher unmet needs, FDA can offer a quicker assessment, with an Early Action in advance of the PDUFA action date.
This research assesses the frequency and importance of such early approvals, with comparisons based on various criterias such as the type of medicines (BLA, New Molecular Entity (NME) NDA and non-NME NDA), if the application received Priority Review or not, the therapeutic area, or the Orphan Designation status. This study highlights the number of drugs that were granted an Early Action in each category, as well as the average difference between the PDUFA target approval date and the actual one.
This study was performed on 433 NDAs/BLAs approvals granted by FDA between January 2015 and June 2018.

When submitting a NDA/BLA, having a precise estimation of the assessment duration is extremely valuable for decision-making, , regulatory and business strategy. This research aims to provide insight to help Pharmaceuticals Industry make a more precise estimate of review expectations, and better understand the key influencing parameters.
Furthermore, by highlighting the type of application that were granted early approvals, this study also highlights FDA's current priorities.

Early Actions granted by FDA: a review of the frequency and importance of NDA/BLA approvals in advance of DUFA action date

DIA Europe 2019

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