Summary: The Food and Drug Administration is holding a public workshop entitled “Development of Antibacterial Drugs for the Treatment of Nontuberculous Mycobacterial Disease." The purpose of the public workshop is to discuss the clinical trial design considerations, including endpoints, related to the development of antibacterial drug products for treatment of nontuberculous mycobacterial (NTM) disease. 

Date and Time: The public workshop will be held on April 8, 2019, from 8:30 a.m. to 5:00 p.m.

Location: The workshop will be held at FDA's White Oak campus, 10903 New Hampshire Ave., Building 31 Great Room, Silver Spring, MD 20993. Entrance for the public workshop participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to Public Meetings at the FDA White Oak Campus.

Requests for Oral Presentations: During online registration you may indicate if you wish to present during a public comment session or participate in a specific session, and which topic(s) you wish to address.  We will do our best to accommodate requests to make public comments.  Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions.  Following the close of registration, we will determine the amount of time allotted to each presenter and the approximate time each oral presentation is to begin, and will select and notify participants by March 29, 2019.  All requests to make oral presentations must be received by the close of registration on March 25, 2019.  If selected for presentation, any presentation materials must be emailed to [email protected] no later than April 3, 2019.  No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

Contact: If further information is needed, please contact Lori Benner and/or Jessica Barnes, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6221, Silver Spring, MD 20993-0002, 301-796-1300.

Streaming Webcast: This public workshop will also be webcast at the following site: https://collaboration.fda.gov/r1s6qm9hgylr/ If you have never attended a Connect Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview.

Webcast Recordings:

• Part 1: https://collaboration.fda.gov/plyfyq2mo3lc/
• Part 2: https://collaboration.fda.gov/pflrh9ipfkhn/
• Part 3: https://collaboration.fda.gov/pgq40axb44fs/
• Part 4: https://collaboration.fda.gov/pnm8884nbxsh/

Transcripts: Transcripts of the workshop will be posted here approximately 30-45 days after the completion of the workshop.

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