Free On Demand: Rationale Webinar

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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