EUAs were less known before COVID than they are now. Between COVID and now Monkeypox, what has been learned about EUA, and where is it going as we move forward? Those are important aspects of today’s discussion with guest, Mike Drues.

Mike Drues is President of Vascular Sciences, an education, training, and consulting company that offers many services to medical device, pharmaceutical, and biotechnology companies.

Listen to the episode to learn what Mike has to say about what EUAs are, what COVID has taught the market about EUAs, and what path FDA reviews are on now.

Some of the highlights of this episode include:

What an EUA is, and when it’s used
An EUA as a pathway to market
What the COVID experience has taught us about EUA
Whether FDA reviews are back to normal
The poor quality of some EUA submissions
Quality requirements for EUA vs. non-EUA devices
What’s new in EUAs beyond COVID
Monkeypox EUA developments
Improvements in EUA qualities as submissions continue
Top takeaways from today’s discussion

Memorable quotes from Mike Drues:

“One of the things I’ve learned in playing this game now for about 30 years is most problems that companies get into, not only are they preventable, they’re predictable.”

“As a matter of fact, FDA estimates that 80% of submissions, 80% of EUA submissions, needed revisions, needed additional information.”

“If you have experience doing these things, you’re going to be more successful. If you don’t have experience doing these things, that’s not a problem; you can’t be an expert at everything, but get somebody to help you.”

“Don’t treat FDA as our elementary school teacher.”

Links:

Mike Drues LinkedIn

Article: FDA wants COVID test developers to shift from EUAs to traditional premarket pathways (RAPS, Sept 27, 2022)

Article: FDA Repeatedly Adapted Emergency Use Authorization Policies To Address the Need for COVID-19 Testing (HHS, Office of Inspector General, Sept 2022) Report

CDRH Website: Monkeypox Emergency Use Authorizations for Medical Devices

Article: FDA issues draft guidance for transitioning medical devices granted EUAs during pandemic

FDA Guidance: Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

FDA Guidance: Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond

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