Meeting | Mixed
Event Title
Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials
August 16, 2024
- Date:
- August 16, 2024
- Time:
- 9:00 a.m. - 4:00 p.m. ET
YouTube Videos
AM Session: https://www.youtube.com/watch?v=_tgtTHDomE0External Link Disclaimer
PM Session: https://youtu.be/0SHLONiHl58?si=OnrvSQ5imdISU5A7External Link Disclaimer
Meeting Location
FDA White Oak Campus
Building 31, Conference Center, The Great Room
10903 New Hampshire Ave.
Silver Spring, MD 20903
Organized by: CDER’s Office of New Drugs
Summary
Discuss issues related to clinical trials meant to support marketing applications for the treatment of negative symptoms of schizophrenia.
Goals and Objectives
Discuss the optimum approach to developing drugs to treat the negative symptoms of schizophrenia.
Disseminate important regulatory considerations for programs designed to evaluate drugs for the treatment of the negative symptoms of schizophrenia.
Meeting Agenda
Speaker Biographies
- Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials Meeting Speaker Biographies (PDF - 915 KB)
Topics for Discussion
Please see the Agenda.
Attendance Information
This meeting will be hybrid. Registration is not required if planning on attending the meeting virtually. The Zoom link to the meeting can be found below.
Registration
In-person Attendee
In-person registration will close at 5:00PM Eastern time on Wednesday, August 7, 2024. To add a calendar notification to your personal calendar you may select one of these links: Add to Google CalendarExternal Link Disclaimer or Add to Outlook CalendarExternal Link Disclaimer.
Virtual Attendee
Registration is not required to attend virtually. Follow this Zoom linkExternal Link Disclaimer to join the meeting on Friday, August 16, 2024, at 9:00AM Eastern Time. You may also add a calendar notification to your personal calendar by selecting one of these links: Add to Google CalendarExternal Link Disclaimer or Add to Outlook CalendarExternal Link Disclaimer.
Special Accommodations
The FDA will make every effort to accommodate people with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email ONDPublicMTGSupport@fda.hhs.gov at least 7 days before the meeting. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.
Visiting the FDA Campus
The entrance for public meeting attendees (non-FDA employees) is through Building 1. All attendees (FDA and non-FDA) attending the meeting in-person must pass through a routine security check procedure like TSA screening at airports. Laptops, tablets, cell phones, keys, car fobs, coins and other metal items from pockets must be put in a bin or tray. Hats will need to be removed. Outer coats, belts, shoes, watches, or other jewelry do not have to be removed. After passing through security screening, meeting attendees will be directed to the meeting room in Building 31.
For parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map.
Zoom Link
Click the link below to join the webinar:
https://fda.zoomgov.com/j/1603934550?pwd=Qld1MXpJYlg4VXVXRC96T0pzSkFIdz09External Link Disclaimer
Passcode: K9tC1#
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Webinar ID: 160 393 4550
Passcode: 616854
International numbers available: https://fda.zoomgov.com/u/ajqpiDEBpExternal Link Disclaimer
Or an H.323/SIP room system:
H.323: 161.199.138.10 (US West) or 161.199.136.10 (US East)
Meeting ID: 160 393 4550
Passcode: 616854
SIP: 1603934550@sip.zoomgov.com
Passcode: 616854
Contact
For additional details, contact the FDAs CDER/OND/Public Meeting Team at
ONDPublicMTGSupport@fda.hhs.gov.
Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.