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FDA’s Role in ASTs and Understanding CLSI Breakpoint Decisions Webinar

CLSI Free On Demand: Rationale Webinar

FDA’s Role in ASTs and Understanding CLSI Breakpoint Decisions 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

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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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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