martes, 25 de julio de 2017

Consumer Information for Medical Devices Update: FDA Announces Representatives for its First Patient Engagement Advisory Committee

FDA Logo
Today, the FDA is pleased to announce the nine voting members selected to serve on the agency’s Patient Engagement Advisory Committee. The FDA’s Patient Engagement Advisory Committee was established to provide perspective to the FDA about the patient experience, and suggest approaches for including patient input in FDA decisions. The committee consists solely of patients and their care-partners (active partner or advocate in a patient’s care and health care decisions).
The following members have been selected to serve for overlapping terms of up to 4 years:
  • Cynthia Chauhan, MSW
  • Paul Conway, BA (Chair)
  • Deborah J. Cornwall, MBA
  • Frederick Downs, Jr., MBA
  • Bennet Dunlap, MS
  • Amye L. Leong, MBA
  • Suzanne Schrandt, JD
  • Katherine Seelman, PhD
  • Monica L. Willis-Parker, MD
The Patient Engagement Advisory Committee 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. More information about the advisory committee members and the first meeting is available in the FDA Voice blog post “FDA Sets Inaugural Meeting of First-Ever Patient Advisory Group.”
The FDA is still accepting nominations for future participation on the patient engagement advisory committee. For information about how to nominate yourself or another candidate to participate in the committee please see the Federal Register notice.
On October 11-12, 2017, the Patient Engagement Advisory Committee will hold its first public meeting to discuss incorporating patient perspectives in the design, conduct and reporting of clinical trials. The FDA is seeking input from the committee and the public on challenges faced by patients in medical device clinical trials, and recommendations for how patient input and engagement can be used to overcome these challenges. 
For information about the upcoming Patient Engagement Advisory Committee meeting, see the Federal Register notice.
For more information about the committee’s purpose and membership, see the Patient Engagement Advisory Committee webpage.
Food and Drug Administration
Center for Devices and Radiological Health

No hay comentarios: