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  4. Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials - 08/16/2024
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Meeting | Mixed

Event Title
Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials
August 16, 2024


Date:
August 16, 2024
Time:
9:00 AM - 4:00 PM ET


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

Topics for Discussion

Coming soon.

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

To attend in-person, please register online at Eventbrite. 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 Calendar or Add to Outlook Calendar.

Virtual Attendee

Registration is not required to attend virtually. Follow this Zoom link 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 Calendar or Add to Outlook Calendar.

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=Qld1MXpJYlg4VXVXRC96T0pzSkFIdz09
Passcode: K9tC1#

Or One tap mobile :
+16692545252,,1603934550#,,,,*616854# US (San Jose)
+16468287666,,1603934550#,,,,*616854# US (New York)

Or Telephone:
Dial(for higher quality, dial a number based on your current location):
+1 669 254 5252 US (San Jose)
+1 646 828 7666 US (New York)
+1 646 964 1167 US (US Spanish Line)
+1 415 449 4000 US (US Spanish Line)
+1 551 285 1373 US (New Jersey)
+1 669 216 1590 US (San Jose)
Webinar ID: 160 393 4550
Passcode: 616854
International numbers available: https://fda.zoomgov.com/u/ajqpiDEBp

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.

Event Materials

Coming soon

 
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