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Patient Engagement Advisory Committee Meeting

Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products

• Meeting Date: Wednesday, October 30, 2024, 10:00 a.m. to 5:00 p.m. ET
• Location: Webcast
• Registration: Registration is only required to participate in the breakout sessions.

The U.S. Food and Drug Administration (FDA) is announcing the Patient Engagement Advisory Committee (PEAC) meeting, where PEAC will discuss and make recommendations on patient-centered informed consent in clinical study of FDA-regulated medical products. The topics for discussion include:

• The informed consent process, and
• Factors to consider when communicating informed consent to clinical study participants to increase the likelihood of participants understanding the key elements of research.

Important Deadlines

• September 25, 2024: Request to make an oral presentation during the public comment period.
• October 3, 2024: Submit written comments.
• October 16, 2024: Register to participate in the virtual breakout scenario discussions.
• October 23, 2024: Request accommodations due to disability by email or by phone 240-507-6496.