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FDA’s Role in ASTs and Understanding CLSI Breakpoint Decisions

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

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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