Webcast of FDA meeting on Thursday 25 April and Friday 26 April

The FDA Drug Development for ME and CFS Public Workshop will be held on Thursday 25 April and Friday 26 April 2013

Note: On Thursday, the meeting begins at 1PM (Eastern Time U.S.)

On Friday the meeting begins at 8:30AM (Eastern Time U.S.)

 

Here is the link for the webcast :

http://www.tvworldwide.com/events/fda/130425/globe_show/default_go.cfm?live=1&type=flv&test=0

 

If this link does not work, there is a backup link on this page

http://www.tvworldwide.com/events/fda/130425/ (right hand side of page, look for the second PLAY button)

 

 

As you watch the webcast, make notes about your answers to these questions from FDA:

Topic 1: Disease Symptoms and Daily Impacts That Matter Most to Patients

  1. 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.)
  2. 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.)
    1. How does the condition affect your daily life on the best days and worst days?
    2. 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

  1. 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.)
    1. What specific symptoms do your treatments address?
    2. How has your treatment regimen changed over time and why?
  2. How well does your current treatment regimen treat the most significant symptoms of your disease?
    1. Have these treatments improved your daily life (for example, improving your ability to do specific activities)? Please explain.
    2. How well have these treatments worked for you as your condition has changed over time?
    3. 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.

 

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