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

Speakers:
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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Details

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

Date of Webinar: December 17, 2019