12. July 2019 - 9:00 till 15:00
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Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) Public Meeting | US. Food and Drug Administration | Friday, 12. July 2019

Meeting Background
In the Federal Register for June 13, 2018 (83 FR 27616), FDA announced the availability of a draft guidance for industry entitled ‘‘Limited Population Pathway for Antibacterial and Antifungal Drugs.’’ This draft guidance provides information on the implementation of section 506(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 3042 of the 21st Century Cures Act, which established the limited population pathway for antibacterial and antifungal drugs (LPAD pathway). This draft guidance is intended to assist sponsors in the development of certain new antibacterial and antifungal drugs for approval under the LPAD pathway.
This draft guidance also is intended to assist sponsors in developing labeling, including prescribing information, patient labeling, and carton/container labeling, that incorporates certain statements required by section 506(h) of the FD&C Act. The LPAD pathway is intended to encourage the development of certain antibacterial and antifungal drugs for limited and specific populations of patients to help address the critical public health and patient care concern that has resulted from the current decline in antibacterial drug research and development as serious antibacterial and antifungal drug-resistant infections increase.
FDA received numerous comments on the draft guidance from a diverse group of stakeholders. FDA also received requests for listening meetings with FDA to provide feedback on the draft LPAD pathway guidance. In view of these requests and to promote transparency, FDA will hold a public meeting at which any stakeholders may present or comment on the draft guidance.
Federal Register Notice (FRN)
Questions on Public Comments
If you have questions regarding submissions to the docket in response to the FRN, for further information, contact:
Sarah WalinskyCenter for Drug Evaluation and Research, Food and Drug Administration10903 New Hampshire Ave.Bldg. 22, Rm. 6242Silver Spring, MD 20993-0002Ph:240-402-4075Email: sarah.walinsky@fda.hhs.gov
Stephen RipleyCenter for Biologics Evaluation and Research, Food and Drug Administration,10903 New Hampshire Ave. Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,Ph: 240-402-7911
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, which topic(s) you wish to address, and an approximate desired length of your presentation, so that FDA can consider these in organizing the presentations. 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.
All requests to make oral presentations must be received by the close of registration on July 1, 2019, at 11:59 p.m. Eastern Time. If selected for presentation, any presentation materials must be emailed to the Sarah Walinsky (see FOR FURTHER INFORMATION CONTACT) no later than July 8, 2019. No commercial or promotional material will be permitted to be presented or distributed at the public meeting. Presenters are encouraged to submit a copy of their presentation and related written material to the docket (see “Comments”) in advance of the public meeting.
Attending a Public Meeting 
Meeting Check-in
Check-in time opens at 8:15 am. 
Visiting FDA
Entrance for the public meeting participants (non-FDA employees) is through Building 1. Please allow time for routine security checks, as procedures will be performed. For parking and security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
Special Accommodations
If you need special accommodations due to a disability, please contact Sarah Walinsky, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6242, Silver Spring, MD 20993-0002, sarah.walinsky@fda.hhs.gov, 240-402-407, no later than July 1, 2019, at 11:59 p.m. Eastern Time.
Webcast Information
This public meeting will be available for online viewing, on the day of the meeting, click on the link to attend: https://collaboration.fda.gov/lppaadpm0719/
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.
FDA has verified the website addresses in this document, as of the date this document publishes in the Federal Register, but websites are subject to change over time.

Will be provided five days before the meeting.
Please be advised that as soon as a transcript is available, a link to the transcript will also be available at www.fda.gov. (See Federal Register Notice for more information)