Tuesday Mar 09, 2021
Expedited drug reviews in the time of COVID-19 (Part 1)
The Coronavirus pandemic has put a spotlight on drug supply and the approval process of new medications. In this episode, we will discuss what frontline pharmacists need to know to about the drug approval process.
Guest speaker:
Amanda Melton, PharmD, BCPS
Senior Clinical Manager
Center for Pharmacy Practice Excellence
Vizient
Moderator:
Gretchen Brummel, PharmD, BCPS
Pharmacy Executive Director
Vizient Center for Pharmacy Practice Excellence
Show Notes:
[01:20] Patients accessing drugs through clinical trials
[02:29] Pharmacists should familiarize themselves with the inclusion and exclusion criteria of clinical trials in order to help clinicians identify good patients candidates
[03:00] ClinicalTrials.gov
[3:17] Patients that don’t qualify for a clinical trial can apply for access through an Expanded Access Program (EAP)
[3:35] What Pharmacists need to know about Expanded Access Programs (EAPs)
[4:26] Goal of the EAP is to get the drug to the patient
[5:03] Step by step process for accessing a drug under the Expanded Access Program (EAP)
[5:42] Investigational New Drug (IND) application
[6:30] Four stakeholders: manufacturer, FDA, patient and Institutional Revenue Board (IRB)
[6:50] Getting access to the FDA by using Form 3926
[7:54] Timing for submitting an EAP
[9:00] How Emergency Use Authorizations (EUAs) differ from Expanded Access Programs (EAPs)
[10:00] How long an EUA lasts
[10:41] When an Emergency Use Authorization (EUA) is issued, it does not mean the drug is approved
[11:15] Why apply for an EUA, instead of a biologics license
[12:07] Issuance of an EUA for a product doesn’t preclude the manufacturer from seeing approval for the product
Links | Resources:
FDA: Emergency Use Authorization Click here
FDA: Expanded Access Click here
NIH U.S. Library of Medicine: ClinicalTrials.gov Click here
Reagan-Udall Foundation for the FDA: COVID-19 Hub Click here
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