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  4. Drug Development Considerations for Empiric Antibacterial Therapy in Febrile Neutropenic Patients - 04/23/2024
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Public | Virtual

Event Title
Drug Development Considerations for Empiric Antibacterial Therapy in Febrile Neutropenic Patients
April 23, 2024

Date:
April 23, 2024
Time:
9:00 a.m. - 5:00 p.m. ET

Description and Summary

The Food and Drug Administration is holding a virtual workshop entitled “Drug Development Considerations for Empiric Antibacterial Therapy in Febrile Neutropenic Patients." The purpose of the public workshop is to discuss clinical trial design and other considerations related to the development of antibacterial drug products for treatment of febrile neutropenia (FN). Discussions are planned around the following topics/areas:

  • Current state of development and the need for antibacterial drugs for empiric therapy in febrile neutropenic patients
  • Design and operational challenges of clinical trials in FN

Request 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. All requests to make oral presentations must be received by April 1, 2024, and must be emailed to Sunita Shukla (Sunita.Shukla@fda.hhs.gov) with the title and brief description of your topic.

We will determine the amount of time allotted to each presenter (no more than 5 minutes) and the approximate time each oral presentation is to begin. We will select and notify participants, if selected as presenters, by April 8, 2024. If selected for presentation, any presentation materials must be emailed to Sunita Shukla (Sunita.Shukla@fda.hhs.gov) no later than April 12, 2024. No commercial or promotional material will be permitted to be presented during the workshop.

Meeting Materials

All meeting materials—including agenda, panelist affiliations/disclosures, speaker slides and Zoom workshop recording—are posted below. A transcripts of the workshop will be posted here approximately 30 days after the completion of the workshop. Please check back regularly for updates.

Event Point of Contact

Antoinette Ziolkowski
Center for Drug Evaluation and Research
Food and Drug Administration
10903 New Hampshire Ave.
Bldg. 22, Room 6221
Silver Spring, MD 20993-0002
301-796-1300

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