Drugs

Facilitating Antibacterial Drug Development for Patients with Unmet Need and Developing Antibacterial Drugs that Target a Single Species

Meeting Information

The Food and Drug Administration (FDA) is announcing a public workshop regarding antibacterial drug development for patients with unmet need and developing antibacterial drugs that target a single species. FDA is interested in discussing the scientific challenges pertaining to such development programs, including enrollment challenges, clinical trial designs and trial population. This public workshop is intended to provide information for and gain perspective from health care providers, other U.S. government agencies, public health organizations, academic experts, and industry on various aspects of drug development for new antibacterial drugs for patients with unmet need and new antibacterial drugs that target a single species. The input from this public workshop will also help in developing topics for future discussion.

 

 Date July 18 and 19, 2016
 Time

July 18th: 8:30 a.m. to 5:00 p.m. 

July 19th: 8:30 a.m. to 4:00 p.m.

 Location The public workshop will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Building 31 Great Room, Silver Spring, MD 20993.  For information regarding the FDA campus map, directions to FDA and security procedures, please visit the FDA website at: Public Meetings at the FDA White Oak Campus
 RegistrationRegistration 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 registration information (including name, title, firm name, address, telephone, and fax number) to: UnmetNeed2016@fda.hhs.gov. Persons without access to the Internet can call 301-796-1300  to register.  Persons needing a sign language interpreter or other special accommodations should notify Ms. Jessica Barnes or Ms. Lori Benner (see Contact Persons) at least 7 days in advance.

Federal Register Notice

Webcast Information:

Please note that this workshop will also be webcast live at: https://collaboration.fda.gov/antibacterialdrug0716/. The audio will be provided via the webcast through your computer speakers.
 

Agenda: 

July 18th Agenda Day 1 (PDF - 71KB)

July 19th Agenda Day 2 (PDF - 66KB)

 Day 1Web Recordings:

 
Day 2 Web Recordings:

Page Last Updated: 08/09/2016
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