The Food and Drug Administration (FDA or agency) is announcing a public workshop regarding Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices (ASTs). This public workshop is intended to facilitate discussion between drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs or ASTs and who wish to coordinate development of these products, such that the AST device could be cleared either at the time of new drug approval or shortly thereafter. The input from this public workshop will also help in developing topics for future discussion.
September 29, 2016
9:00 a.m. to 4:00 p.m.
The public workshop will be held at the Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910. The hotel’s phone number is 301-589-0800.
Registration is free for the public workshop. Interested parties are encouraged to register early. Seating will be available on a first-come, first-served basis. To register electronically, e-mail your registration information (including name, title, firm name, address, telephone number, and fax number) to AntimicrobialSusceptibilitytestingWorkshop2016@fda.hhs.gov. Persons without access to the Internet can call 301-796-1300 to register. If you need special accommodations due to a disability, please contact Jessica Barnes or Lori Benner (see Contact Persons above) at least 7 days in advance.
Speaker slides will be made available shortly before or on the day of the workshop on this site. Transcripts will be made available approximately 45 days after the workshop.
This workshop will not be available via webcast.
- Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices - Draft Guidance for Industry and Food and Drug Administration Staff
- Panelists and Disclosures
- Transcript: Thursday, September 29, 2016
- Coordinated Development of Antimicrobial Drugs and AST Devices
- Overview of AST Device Clearance Process: CDRH Perspective
- Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices Workshop
- AST in 2016: New Drugs
- FDA Workshop Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Tests
- AST Device Development: The Pharma Perspective
- How to Develop and Obtain Regulatory Approval of Commercial Antimicrobial Susceptibility Tests in a Timely Manner
- Coordinating development of new antimicrobials and susceptibility testing methods
- How Can CLSI Help?