Per the notice below, the United States Food and Drug Administration (FDA) is holding a virtual meeting on informed consent in clinical studies for FDA regulated medical/dental products.

Patient Engagement Advisory Committee Meeting: Patient-Centered Informed Consent in Clinical Study of FDA-Regulated Medical Products

 The U.S. Food and Drug Administration (FDA) is announcing the Patient Engagement Advisory Committee (PEAC) meeting will be held virtually on October 30, 2024.  During this meeting, 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.

•  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.

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.

Questions?