The Food and Drug Administration (FDA invites the community and patients served by the National Kidney Foundation Serving Maryland and Delaware to an upcoming public meeting on Patient-Focused Drug Development for Patients Who Have Received an Organ Transplant.
When: September 27, 2016
Time: 9 a.m. to 5 p.m. (EDT)
Location: FDA Campus in Silver Spring, Maryland.
Specific details are outlined below.
The purpose of the meeting is to gather patients’ perspectives on the impact of organ transplantation on daily life, patient views on receiving an organ transplant, and decision factors taken into account when selecting a regimen for organ transplantation management.
This meeting is an exciting opportunity for patients to bring their voice to FDA and the drug development process. We’re asking you to help make this meeting a success by encouraging patients to participate either in-person or through the live webcast. FDA needs your help to make this meeting a success. Please direct patients to the links below to register, explore the discussion questions and meeting format, and find more information on FDA’s Patient-Focused-Drug Development initiative.
Meeting website: Public Meeting on Patient-Focused Drug Development for Patients Who Have Received an Organ Transplant
Background: Watching these webinars on FDA and Patient-Focused Drug Development in advance may be helpful in preparing for the meeting.
The meeting format maximizes patient participation. For each discussion topic, a small panel of patients or caretakers will prove brief comments to start the dialogue. The panel comments will be followed by a facilitated discussion with other patients and patient representatives in the audience. Patients or caregivers who would like to be considered to be on the opening panel can indicate that as part of registration. They will be asked to send a short summary of their responses to the discussion questions (posted on our registration site) to PatientFocused@fda.hhs.gov.
In the afternoon, FDA will hold a workshop and provide information for and gain perspective from patients, patient advocacy organizations, health care providers, academic experts, and industry on various aspects of clinical development of drug products intended for patients who have received organ transplants. The input from this public meeting will help in developing topics for future discussion.
Discussion topics for the afternoon will include the following: current treatment consideration, considerations regarding adherence to treatments, clinical trial designs, and clinical trial endpoints.
We look forward to this exciting meeting and hope to see you there. If you have any questions, please feel free to contact us at PatientFocused@fda.hhs.gov.