CLSI Free On Demand: Rationale Webinar
FDA’s Role in ASTs and Understanding CLSI Breakpoint Decisions
Recorded on December 17, 2019
First, learn about the FDA’s Role in increasing the availability and reliability of ASTs:
- The 21st Century Cures Act and ASTs
- Introduction to the FDA breakpoint recognition/identification process and the FDA Interpretive Criteria Webpages
- Improving AST availability for new antibacterial drugs
- Working together to update breakpoints for patient care and public health
Then, learn about CLSI’s commitment to ensure updated and new breakpoints are available to clinical laboratories:
- Review the CLSI’s rationale document process
- Discuss how laboratories can use the rationale documents in day to day practice
- Explore how laboratories can participate in the process to ensure ASTs are available in a timely manner
Speakers:
John Farley, MD, MPH, Deputy Director, Office of Antimicrobial Products, US Food and Drug Administration
Romney Humphries, PhD, D(ABMM), Chief Scientific Officer, Accelerate Diagnostics, Inc.
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Details
Chairholder: John Farley, MD, MPHUS; Romney Humphries, PhD, D(ABMM)
Date of Webinar: December 17, 2019
CLSI Free On Demand: Rationale Webinar Additional Details
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