The Food and Drug Administration (FDA) held a Patient-Focused Drug Development meeting on Parkinson’s disease on September 22, 2015. Watch the full meeting on the FDA website. (The Parkinson’s meeting is listed as “Meeting Recording Part 3” and “Meeting Recording Part 4”.)
The meeting was devoted to obtaining patient perspectives on the impact of Parkinson’s disease on daily life and patient views on currently available treatment approaches. The meeting included two panels of patients, focused on specific topics and questions, and was followed by a facilitated discussion inviting comments from all participating patients and caregivers, including those watching via webcast.
Take the Parkinson’s Survey
The Parkinson’s Action Network (PAN) and its Unified Partners invite you to participate in the a community-wide survey to inform the FDA as it works to integrate the experiences of people with Parkinson’s, their families, and caregivers in its operations.
The survey consists of 17 questions based on those initially posed by FDA for the September meeting. While you are strongly encouraged to complete every question, it is not required to submit your survey responses. The survey is designed to be taken in approximately 15-20 minutes, but you may take as much time as needed.
No personally identifiable information will be collected, and your responses will remain anonymous. The deadline to take the survey is October 30, 2015.
Continue to Provide Your Feedback
The FDA is interested in receiving patient input addressing these questions through written comments. We encourage you to submit comments to ensure that the FDA understands the patient perspective and experience when developing and approving medications and devices. The deadline for comments is November 23, 2015.
To submit your comments online:
- Visit http://bit.ly/fda-pd-comments
- Click “Submit Comments” at top-right corner of page.
- Follow instructions to submit your answers to the questions or provide your other thoughts and comments.
You may also submit comments via mail to:
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852
All comments should be identified with the docket number (FDA-2012-N-0967-0747).
Help Spread the Word
It is important to get the word out about the survey and open docket for comments. The more varied and diverse voices the FDA hears from, the better for the entire Parkinson’s community.
Please join us by using this communications toolkit to help spread the word through your own social media accounts, support groups, etc.
About the Patient-Focused Drug Development Meetings
FDA’s Patient-Focused Drug Development initiative is a commitment under the fifth authorization of the Prescription Drug User Fee Act (PDUFA V) that aims to more systematically gather patients’ perspectives on their disease and its impact on daily life, the types of treatment benefit that matter most to patients, and adequacy of the available therapies. As part of this commitment, FDA is holding at least 20 public meetings, each focused on a specific disease area. The Voice of the Patient reports will summarize the input provided by patients and patient representatives at each of these public meetings. Learn more.
Questions for PAN
Contact Jamie Tucker, PAN’s senior government relations manager, at firstname.lastname@example.org.