Final agenda for FDA April 25/26 2013 Drug Development for ME and CFS public workshop
You have until 2 August to submit your comments to FDA via this docket – http://www.regulations.gov/#!submitComment;D=FDA-2012-N-0962-0004
Online comments are limited to 2000 characters however, you can attach documents and PDFs.
INTERESTING DEVELOPMENT as of 19 April 2013:
Comments and attachments can include YouTube links. For the severely ill this is a great way to be seen even though they can’t get to the meeting.
FDA wants your answers to these questions:
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients
- What are the most significant symptoms that you experience resulting from your condition? (Examples may include prolonged exhaustion, confusion, muscle pain, heat or cold intolerance.)
- What are the most negative impacts on your daily life that result from your condition and its symptoms? (Examples may include difficulty with specific activities, such as sleeping through the night.)
- How does the condition affect your daily life on the best days and worst days?
- What changes have you had to make in your life because of your condition?
Topic 2: Patients’ Perspectives on Current Approaches To Treating CFS and ME
- What treatments are you currently using to help treat your condition or its symptoms? (Examples may include FDA-approved medicines, over-the- counter products, and other therapies, including non-drug therapies such as activity limitations.)
- What specific symptoms do your treatments address?
- How has your treatment regimen changed over time and why?
- How well does your current treatment regimen treat the most significant symptoms of your disease?
- Have these treatments improved your daily life (for example, improving your ability to do specific activities)? Please explain.
- How well have these treatments worked for you as your condition has changed over time?
- What are the most significant downsides of these treatments (for example, specific side effects)?
In addition to the questions that the FDA asked, please provide comments about your lab/test abnormalities – linked to symptoms and dysfunction where possible – and indicate how those abnormalities changed as a result of treatment if known.
Thank you to Ms Spotila for working with the FDA to get inclusion of YouTube links.