community download

"FDA Regulation of Clinical Microbiology and AST Diagnostic Devices"

information we require

please check before submitting



Privacy statement »

Manage your email preferences »

Remember my details Information

Information
Remember my details
We place a 'cookie' on your computer so next time you visit us you don't need to fill in all these details

Ribhi Shawar of FDA joined us for World Anti-Microbial Resistance Congress USA 2015 to discuss 'FDA regulation of clinical microbiology and AST diagnostic devices' .
 
In this presentation, learn about some examples of challenges in data presentation/analysis as well as scientific and regulatory process understanding.
 
Download the presentation to understand more about:
  • Progress in microbial diagnostics, including AMR
  • Highlights of efforts and initiatives
    • Efforts on coordinated development between CDRH and CDER
    • The joint interagency FDA/CDC: Antimicrobial-Resistant Isolates Bank
    • Curated Genomic Sequence Debates
  • Resources 

..and much more!

 

Get your copy here!
 
To find out more about progress in AMR diagnostics and the efforts of the FDA against AMR , attend  World Anti-Microbial Resistance Congress USA 2016  held  September 8-9  in Washington, DC  .