FDA Guidance: Coordinating susceptibility (AST) device approval with drug approval

Dear All:

FDA has now posted a final guidance entitled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test (AST) Devices” that discusses the ways that FDA seeks to:

  • Minimize lag time between drug approval and AST device* approval and
  • Provide recommendations on how AST developers and drug developers can coordinate their work with each other and with the FDA.
  • *Aside: The terminology “AST device” can be perplexing the first time you encounter it. In brief, an AST device is an in vitro diagnostic product which is a complete method (manual, automated, or semi-automated) intended for doing susceptibility testing. It usually includes something physical (e.g., a disk that contains drug that can be used for agar diffusion testing) as well as the labeling directions for how to use the device 

The new guidance is a brief document and emphasizes FDA’s desire to see AST devices become available in parallel with drug approval if possible. If you’re not familiar with why this isn’t always easy to achieve, this paper is an excellent introduction to the problem:

  • Humphries RM, Hindler JA. Emerging Resistance, New Antimicrobial Agents … but No Tests! The Challenge of Antimicrobial Susceptibility Testing in the Current US Regulatory Landscape. Clin Infect Dis. 2016;63(1):83-8. (link to paper)

FDA will discuss the new guidance at a webinar on Tuesday, February 12, 2019, 3-4p EST. Click here for webinar details. You can also contact the Division of Industry and Consumer Education (DICE) in the Center for Devices and Radiological Health at 1-800-638-2014, 301-796-7100 or dice@fda.hhs.gov.

All best wishes, –jr

John H. Rex, MD | Chief Medical Officer, F2G Ltd. | Expert-in-Residence, Wellcome Trust. Follow me on Twitter: @JohnRex_NewAbx. See past newsletters and subscribe for the future: http://amr.solutions/blog/

Upcoming meetings of interest to the AMR community:

  • 29 Jan 2018 (REVIVE webinar): “Clinical development for non-developers Part 3: Antibacterial Drug Enhancer Combinations and Non-traditional Products.” Register here.
  • 4-5 Feb 2019 (London): Hamied Foundation UK-India Antimicrobial Resistance Meeting 2019. This is a 2-day meeting focused on building research links between the UK and India with the specific aim of jointly addressing the challenge of AMR. Register here.
  • 14-15 Mar 2019 (Berlin): BEAM-, CARB-X-, Novo REPAIR-, DZIF-, ND4BB-ENABLE-sponsored (among a long list!) Berlin Conference on Novel Antimicrobials and AMR Diagnostics. Details here. Poster submissions are being accepted through 9 Jan (details here).
  • 21-22 Mar 2019 (Birmingham, UK): BSAC Spring Conference.
  • 26 Mar 2019 (London, UK): Sponsored by The Economist, a 1-day symposium entitled “Antimicrobial Resistance: Preventing an antibiotic apocalypse.” Register here.
  • 13-16 Apr 2019 (Amsterdam): Annual ECCMID meeting
  • 16-18 Apr 2019 (Utrecht): ICOHAR, International Conference on One Health Antimicrobial Resistance. Organized by the ESCMID Study Group for Veterinary Microbiology (ESGVM).
  • 24-26 Apr 2019 (Boston): Annual SHEA (Soc. for Hospital Epidemiology of America) Spring meeting
  • 6-11 May 2019 (Ljubljana, Slovenia): 37th Annual Meeting of the European Society for Paediatric Infectious Diseases (ESPID). Details here.
  • 3-6 Jun 2019 (Philadelphia): Annual BIO meeting
  • [NEW] 10-11 June 2019 (Research Triangle Park, NC): AMR Action Summit on R&D and Commercialization. Sponsors include the British-American Business Council, the UK Gov’t, CARB-X, the NC Biotechnology Center, and others. Details here.
  • 20-24 June 2019 (San Francisco): Annual ASM Microbe meeting.
  • [Mark your calendar now!] 3-6 Sep 2019 (Boston). Annual ASM-ESCMID Conference on Antibiotic Development. The Bootcamp series will continue on 3 Sep with the main meeting on 4-6 Sep. Mark your calendar now and check back here for details.
  • 6-8 Sep 2019 (Bilbao, Spain): 5th ESCMID conference on Vaccines. Check back here for details.
  • 2-6 Oct 2018 (Washington, DC): IDSA’s annual IDWeek meeting.
  • 19-27 Oct 2019 (Annecy, France): International Course on Antibiotics and Resistance (ICARe) – A soup-to-nuts intensive residential training program on all things AMR, especially R&D for new antibiotics. See this link for details.

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