))
Future of the Emergency Use Authorization (EUA): COVID, Monkeypox & Beyond
Manage episode 374949620 series 3504807
Greenlight Guru + Medical Device Entrepreneurs에서 제공하는 콘텐츠입니다. 에피소드, 그래픽, 팟캐스트 설명을 포함한 모든 팟캐스트 콘텐츠는 Greenlight Guru + Medical Device Entrepreneurs 또는 해당 팟캐스트 플랫폼 파트너가 직접 업로드하고 제공합니다. 누군가가 귀하의 허락 없이 귀하의 저작물을 사용하고 있다고 생각되는 경우 여기에 설명된 절차를 따르실 수 있습니다 https://ko.player.fm/legal.
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:
CDRH Website: Monkeypox Emergency Use Authorizations for Medical Devices
Article: FDA issues draft guidance for transitioning medical devices granted EUAs during pandemic
Mike on Medtech: COVID-19 (Medical Product Outsourcing Magazine, April, 2020), Part 1 here
Mike on Medtech: COVID-19 (Medical Product Outsourcing Magazine, April, 2020), Part 2 here
350 에피소드
공유
