The Impact of the FDA's Recent Shift on COVID LDTs and Beyond
Recorded
Wednesday, January 26, 2022 · 12:00 p.m.
ABOUT THIS WEBINAR
In late November, the U.S. Department of Health and Human Services (HHS) withdrew a policy regarding laboratory developed tests (LDTs) established during the Trump Administration that directed the FDA not to enforce premarket review requirements for LDTs. While the policy was initially established to allow new COVID-19 tests to reach consumers more quickly, the FDA contended the rule limited its ability to address certain problematic tests.
However, this sudden shift has left laboratories developing new COVID tests with more questions than answers regarding the steps that now must be taken to receive Emergency Use Authorization (EUA) for their LDTs prior to clinical use.
During this webinar, we will welcome Gail H. Javitt, Director, Hyman Phelps & McNamara, P.C., to discuss:
• The implications of the FDA’s recent policy shift.
• How the EUA process for COVID LDTs is impacted.
• How this regulation could affect other LDTs moving forward.
Business & finance
Professional development
Science & tech
ADDITIONAL INFO
Categories:
Business & finance
Professional development
Science & tech
When:
Wednesday, January 26, 2022 · 12:00 p.m.
Eastern Time (US & Canada)
Duration: 1 hour
Price:Free
Language:English
Who can attend?Everyone
Dial-in available?
(listen only):Yes.
Dial-in Number:
Please register for this Webinar to view the dial-in info.
Jon has over 18 years of experience in the clinical lab industry. Spearheading trends in the industry, he created one of the nation's first firms solely dedicated to recruiting for clinical laboratories as well as the first firm dedicated to...
Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, and human cellular, and tissue-based products (HCT/Ps) throughout the product life cycle and has successfully...
We provide comprehensive solutions to challenges facing the medical laboratory community through Lab Management, Recruiting, Consulting, RCM, and Lab Director Services. Our mission is to make Quality Laboratory Testing More Accessible.