124 - The ABCs of EUAs: Understanding FDA Emergency Use Authorizations

HelixTalk - Rosalind Franklin University's College of Pharmacy Podcast

Sean P. Kane, PharmD, BCPS

Health & Fitness, Medications, Rosalindfranklin, Rfums, Pharmacy, Pharmd, Pharmacist, Medicine, Drugs

5 • 644 Ratings

🗓️ 5 January 2021

⏱️ 28 minutes

🔗️ Recording | iTunes | RSS

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Summary

In this episode, we discuss the FDA·s Emergency Use Authorization (EUA) process and review the resources available to healthcare providers when an EUA for a drug therapy is approved.

Transcript

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0:00.0	Welcome to Helix Talk, an educational podcast for healthcare students and providers covering real-life clinical pearls, professional pharmacy topics, and drug therapy discussions.
0:11.0	This podcast is provided by pharmacists and faculty members at Rosal Franklin University College of Pharmacy.
0:17.0	This podcast contains general information for educational purposes only. This is not professional
0:22.4	advice and should not be used in lieu of obtaining advice from a qualified health care provider.
0:27.2	And now on to the show.
0:31.7	Welcome to Helix Talk episode 124. I'm your co-host, Dr. Kane. Unfortunately, Dr. Patel is not with us today, but she will be
0:39.4	back with our next episode. So I am flying solo today, and the title of today's episode is the
0:45.1	ABCs of EUAs, Understanding FDA Emergency Use Authorizations. So this has definitely been in the news
0:53.3	recently with two newly approved COVID-19
0:56.0	vaccines. But as we'll talk about in today's episode, there's actually a number of other
1:00.3	therapies that have undergone this emergency use authorization from the FDA. So we're going to talk
1:06.0	about what that is. And as a health care provider, how can you stay up to date on this very fast-moving market of these
1:13.0	emergency use authorization medications? So to kind of set the tone for today's episode, I want you
1:19.5	to think about sitting back, relaxing, having your pandemic agnog during the holiday season,
1:24.8	and during your Zoom call with your family or friends, Uncle Bill says,
1:28.5	how safe is that COVID-19 vaccine? And you ask yourself, what is the best way to answer that
1:33.4	question? What is the best resource to figure out the safety of that vaccine? Or maybe you're
1:39.7	wrapping up the tasks at a hospital that you work at. And before you go home, a physician, let's say Dr.
1:47.0	Strangelove, pops his head into your office and says, what's this new medication I heard about called
1:53.7	Casavirmaab with Mdevimab? How does it work and does it work at all? And again, asking yourself
1:59.9	the question, how can you find more information about this combination monoclonal antibody therapy
2:04.6	that was approved under this emergency use authorization process?
	...

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