FDA: Evaluating the Negative Symptoms of Schizophrenia in Clinical Trials

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

Dates and Registration:

The public meeting will be in-person and online on Friday, August 16, 2024, from 9:00 a.m. to 4:00 p.m. ET.

In-Person Attendance (registration required):

Registration is required only for in-person attendance. Registration will be available until 5:00 p.m. on Wednesday, August 7, 2024. Registrants will receive a confirmation when they have completed the registration process. Before the meeting, all pre-registered in-person attendees will receive visitor information (parking, shuttle, security, and campus information) via email. To add a calendar notification to your personal calendar, select one of the following links Add to Google Calendar or Add to Outlook Calendar.

The FDA will make every effort to accommodate people with physical disabilities or special needs at public meetings. If accommodations are required due to a disability, please email us at [email protected] at least 7 days before the meeting. The FDA White Oak campus and shuttle are generally accessible to people with physical disabilities.

Online Attendance (Zoom) (registration not required):

This meeting will be available for online viewing on the day of the meeting via Zoom. Registration is not required if attending virtually. Follow this Zoom link to join on Friday, August 16, 2024, at 9:00 a.m. Eastern Time. You may add a calendar notification to your personal calendar, by selecting one of the following links: Add to Google Calendar or Add to Outlook Calendar.

Security Screening (in-person attendees only):

All attendees (FDA and non-FDA) attending the meeting in-person will be required to pass through security. This process is like TSA security 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.

Please be aware: Federal law prohibits the following items on Federal property: firearms, explosives, archery equipment, weapons, knives with blades over 2½ inches, alcoholic beverages, open containers of alcohol and marijuana (cannabis).

Meeting Materials:

A final agenda will be available via the meeting website before the meeting. All other meeting materials, including recordings, speaker slides, and transcripts, will be available after the meeting. Please visit the meeting website for additional information.

Contact:

If further information is needed, please contact us at: OND Public Meeting Support Team [email protected].

Host or Publisher U.S. Food and Drug Administration