FDA Patient Engagement Advisory Committee Meeting - Nov 15th

Patient Affairs Staff (PAS)

Food and Drug Administration

U.S. Department of Health and Human Services

FDA announces Patient Engagement Advisory Committee meeting on utilizing real world data from patient-driven platforms that connect and empower patients

On November 15, 2018, the FDA’s Patient Engagement Advisory Committee (PEAC) will hold its second public meeting to discuss how the FDA can use patient-driven platforms, such as those that utilize social media, digital health technology and patient registry data, to inform the regulatory evaluation of medical devices.

Date: Thursday, Nov 15th

Time: 8 am – 5 pm ET

Location: Hilton Washington DC North/Gaithersburg, 620 Perry Parkway in Gaithersburg, MD

To speak at the Open Public Hearing: Submit a brief statement of the general nature of the evidence or arguments you wish to present, the names and addresses of proposed participants, and the approximate time requested to make your presentation to Letise Williams at Letise.Williams@fda.hhs.gov by Oct. 15th

To submit written comments: Email Letise Williams at Letise.Williams@fda.hhs.gov by Oct. 23rd

About the meeting: The number of people turning to the Internet to find and share health information continues to grow.  Social media channels aid the creation of virtual patient communities where patients and health care consumers can share their health experiences and seek information from one another. These platforms are potentially rich sources of patient-generated health data, which could be used in some cases as real-world evidence to help protect public health and promote health care innovation. The Committee will discuss whether and how the FDA can harness patient-driven online and mobile platforms to better engage with patients and consumers, as well as to collect and evaluate real-world data in the form of health information provided by patients and consumers.

About PEAC: The Patient Engagement Advisory Committee (PEAC) is the first FDA advisory committee focused wholly on patients and patient-related issues. Members, including patient representatives, a consumer representative, and a non-voting industry representative (selected based on the topic), provide advice to the Commissioner of the FDA on complex issues relating to medical devices, the regulation of devices, and their use by patients. Interested in becoming a member of PEAC? FDA is recruiting! Contact Letise Williams, Designated Federal Official, at Letise.Williams@fda.hhs.gov or 301-796-8398.

More Information:

• PEAC meeting details: View the Federal Register Notice
• Social Media: Use #PEAC2018 to stay connected