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.

 

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

 

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

 

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

 

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: modernpracticepodcast@vizientinc.com

Steven’s email: steven.lucio@vizientinc.com

Jeni’s email: jeni.hayes@vizientinc.com

FDA’s accelerated approval update page: Click here

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

 

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