The agency plans to model the collaborative after the European Medicines Agency’s Patients’ and Consumers’ Working Party, a program that engages patients in regulatory activities, wrote Nina L. Hunter, PhD, deputy director for medical programs in the FDA’s Office of Medical Products and Tobacco, and Rachel E. Sherman, MD, the agency’s principal deputy commissioner.
The FDA’s patient affairs staff in the Office of Medical Products and Tobacco will spearhead the collaborative in conjunction with the agency’s medical product centers and Office of External Affairs. The patient engagement collaborative will organize an ongoing forum for patients to discuss how to improve transparency and facilitate meaningful engagement in the medical product development process.
The FDA will work to incorporate these patient perspectives into its regulatory decision-making processes, according to Dr. Hunter and Dr. Sherman.
For the nomination process, the FDA is seeking patients who have experience with various diseases, caregivers who support patients and representatives from patient groups.
To access the Federal Register‘s notice on the nomination process, click here.
More articles on patient engagement:
New patients wait an average of 2.7 weeks to be seen: 5 things to know
Can participating in Facebook groups improve patient satisfaction? 4 findings
Patients find online portals difficult to understand, study finds
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