FDA’s Role in ASTs and Understanding CLSI Breakpoint Decisions

Free Rationale Webinar:

FDA’s Role in ASTs and Understanding CLSI Breakpoint Decisions

December 17, 2019 | 1:00-2:00 PM Eastern (US) Time

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, MPHUS, Deputy Director, Office of Antimicrobial Products, US Food and Drug Administration
Romney Humphries, PhD, D(ABMM), Chief Scientific Officer, Accelerate Diagnostics Inc.

Earn 1.0 PACE CE® Credit. Free registration required. Space is limited.

Members: FREE

Nonmembers: FREE
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Chairholder: John Farley, MD, MPHUS; Romney Humphries, PhD, D(ABMM)

Date of Webinar: December 17, 2019