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EVENT TITLE

Addressing Challenges in Inhaled Antifungal Drug Development; Public Workshop

DESCRIPTION/SUMMARY

This public workshop is currently being scheduled and planned as a virtual meeting. The Food and Drug Administration (FDA, the Agency, or we) is announcing the following virtual public workshop entitled "Addressing Challenges in Inhaled Antifungal Drug Development." The purpose of the virtual public workshop is to discuss the challenges and clinical trial design considerations for developing inhaled antifungal drugs.

ABOUT THE PUBLIC WORKSHOP

FDA is particularly interested in discussing the challenges in conducting clinical trials for inhaled antifungal drugs. Discussions are planned around the following topics areas:

• Clinical need for inhaled antifungal drugs for clinical conditions such as allergic bronchopulmonary aspergillosis and invasive pulmonary aspergillosis
• Trial design considerations, including trial populations and endpoints

REGISTRATION

This meeting will be held in virtual format only. Registration is required for online attendance and will be available until 5pm on September 24, 2020.

To register for this workshop, visit https://www.eventbrite.com/e/addressing-challenges-in-inhaled-antifungal-drug-development-tickets-109002310846

REQUEST FOR ORAL PRESENTATIONS

During online registration you may indicate if you wish to present during a public comment 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. 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 September 14, 2020. All requests to make oral presentations must be received by September 7, 2020. If selected for presentation, any presentation materials must be emailed to [email protected] no later than September 21, 2020. No commercial or promotional material will be permitted to be presented or distributed at the public workshop.

ONLINE ATTENDANCE (WEBCAST)

This meeting will be available for online viewing, on the day of the meeting via the following link: https://collaboration.fda.gov/antifungaldrugs092520/
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

EVENT POINT OF CONTACT

Lori Benner and/or Antoinette Ziolkowski, 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.

WEBCAST RECORDING

• https://collaboration.fda.gov/pwqhyf9fqw74/

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