Thursday Mar 09, 2023

The promise and limitations of expedited approval, Part 1

During the COVID pandemic, the vaccine approval process went from eight years to a few months. In addition, the FDA has used several expedited approval pathways, starting in the 1990s with HIV treatments and continuing today. On the next two episodes, Tom talks with two leading experts on these various approval pathways, what medications are on the approval fast track, and other considerations regarding expedited approval today.


Tomas Villanueva, DO, MBA, FACPE, SFHM
Senior Principal, Clinical Operations and Quality


Jeni Hayes, PharmD, MSPharm, BCPS
Senior Clinical Manager, Pharmacy Outcomes
Center for Pharmacy Practice Excellence


Steven Lucio, PharmD, BCPS
Senior Principal, Pharmacy Solutions
Center for Pharmacy Practice Excellence


Show Notes:

[01:32] Vaccine approval path before and after COVID

[02:59] Rationale for accelerated approval; reducing preapproval research

[05:14] Examples of expedited approval recently – reducing the eight-year duration

[07:32] Rundown of various approval routes


Links | Resources:

To contact Modern Practice:

Steven’s email:

Jeni’s email:

FDA’s accelerated approval update page: Click here

Vizient Pharmacy Market Highlights – Dec. 2022: PMO322_PharmacyMarketOutlook_Highlights.pdf


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