- July 12, 2019
FDA White Oak Campus
Building 31, Room 1503 A – Great Room
10903 New Hampshire Ave.
Silver Spring, MD 20993
FDA Campus Information
The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.” The purpose of the meeting is to provide a public forum for FDA to listen to comments on the draft guidance for industry, “Limited Population Pathway for Antibacterial and Antifungal Drugs,” that was published in the Federal Register on June 13, 2018. FDA is also reopening the comment period on this draft guidance for comments to be submitted for consideration before we finish work on the final version of the guidance.
Federal Register Notice
Register online at: https://www.eventbrite.com/e/limited-population-pathway-for-antibacterial-and-antifungal-drugs-lpad-public-meeting-tickets-54015228001 by July 1, 2019, 5:00 p.m., EST
Opens at 8 a.m. - 9 a.m.
Note Online registration is strongly encouraged, seats may be limited
Requests for Oral Presentations
During online registration you may indicate which topic(s) you wish to address, and an approximate desired length of your presentation, so that FDA can consider this information 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 present.
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 we will select and notify participants.
Deadline to Request to make an Oral Presentations
July 1, 2019, at 11:59 p.m. EST
Deadline for Submission of Oral Presentation Materials
July 8, 2019 at 12 p.m. EST
Note If selected to present, all presentation materials must be emailed to Sarah.Walinsky@fda.hhs.gov by the submission deadline)
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 ADDRESSES section of the FRN) in advance of the public meeting.
Streaming Webcast (Attending Online)
The meeting can be accessed online on the meeting date by clicking the link below to participate:
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.
Final Agenda (PDF - 50 KB)
Note Only printed copies of the agenda, affiliations and disclosures will be provided during the meeting
LPAD Public Meeting - Part I
- Angula. David. LPAD Scynexis (PDF - 199KB)
- Cox, Edward. LPAD Introduction (PDF - 595KB)
- Rex, John. LPAD Antibiotic RD 3.0 (PDF - 143KB)
- Wittmer, Lisa. LPAD Past Precedents and Future Scenarios (PDF - 49KB)
- Mounts, Phoebe. LPAD CorMedix (PDF - 832KB)
- Pypstra, Rienk. LPAD Industry Comments (PDF - 102KB)
- Walsh, Thomas. LPAD Meeting the Challenges of Uncommon and Emerging Mycoses (PDF - 205KB)
Public Meeting Contact Information
If further information is needed, 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, (240) 402-4072.
|LPAD Pathway Agenda||pdf (49.95 KB)|
|Angula, D_PDF||pdf (198.24 KB)|
|Cox, E_Intro||pdf (594.37 KB)|
|Rex, J_Antibiotic||pdf (142.99 KB)|
|Wittmer, L_Past Precedents||pdf (48.37 KB)|
|Mounts, P.LPAD_CorMeix||pdf (923.23 KB)|
|Pystra, R_LPADIndustry||pdf (101.82 KB)|
|Walsh, T_MeetingTheChallenges||pdf (204.95 KB)|
|Transcript_LPAD_pdf||pdf (2.91 MB)|