Microbiology

CLSI AST FDA Webinar

FDA’s Role in ASTs and Understanding CLSI Breakpoint Decisions

This on-demand webinar will help labs understand the FDA's recognition and identification process of breakpoints for antimicrobial susceptibility (AST) testing and the FDA interpretive Criteria Webpages. Ensure your laboratory grasps how CLSI's breakpoint decisions help: 

  • Improve AST availability for new antibacterial drugs.
  • Assist in collaboration in updating breakpoints for the best possible patient care and approach to public health. 
  • Increase understanding about CLSI's role and commitment to ensure updated and new breakpoints are available to clinical laboratories worldwide. 

Watch on-demand to learn about how laboratories implement crucial rationale documents in day to day practice and how your laboratory can participate to ensure AST is widely available and timely.

December 17, 2019

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Scope

Learning Objectives

  1. Discuss how laboratories and AST device manufacturers need to be able to use up-to-date Susceptibility Test Interpretive Criteria (STIC) or breakpoints for the reports provided to physicians to inform appropriate treatment choices. 
  2. Review how the identification of patients who have certain types of resistant bacteria is also essential for infection control practices. 
Previously Titled

Learning Objectives

  • Discuss how laboratories and AST device manufacturers need to be able to use up-to-date Susceptibility Test Interpretive Criteria (STIC) or breakpoints for the reports provided to physicians to inform appropriate treatment choices. 
  • Review how the identification of patients who have certain types of resistant bacteria is also essential for infection control practices. 
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.
Supporting Resources
CLSI MR03
Meropenem Breakpoints for Acinetobacter spp.
Companion
Microbiology
Free
CLSI MR02
Fluoroquinolone Breakpoints for Enterobacteriaceae and Pseudomonas aeruginosa
Companion
Microbiology
Free
CLSI MR06
Daptomycin Breakpoints for Enterococci
Companion
Microbiology
Free
CLSI MR04
Azithromycin Breakpoint for Neisseria gonorrhoeae
Companion
Microbiology
Free
Scope

Learning Objectives

  1. Discuss how laboratories and AST device manufacturers need to be able to use up-to-date Susceptibility Test Interpretive Criteria (STIC) or breakpoints for the reports provided to physicians to inform appropriate treatment choices. 
  2. Review how the identification of patients who have certain types of resistant bacteria is also essential for infection control practices. 
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.
Supporting Resources
CLSI MR03
Meropenem Breakpoints for Acinetobacter spp.
Companion
Microbiology
Free
CLSI MR02
Fluoroquinolone Breakpoints for Enterobacteriaceae and Pseudomonas aeruginosa
Companion
Microbiology
Free
CLSI MR06
Daptomycin Breakpoints for Enterococci
Companion
Microbiology
Free
CLSI MR04
Azithromycin Breakpoint for Neisseria gonorrhoeae
Companion
Microbiology
Free