There’s still time to submit comments to FDA docket on Drug Development for ME and CFS

Did you know, as of July 17th 2013, only 193 comments have been submitted to the FDA docket on Drug Development for ME and CFS?

Comments (from any country) can still be submitted (http://www.regulations.gov/#!submitComment;D=FDA-2012-N-0962-0004 ) until August 2, 2013.

Remember you can attach a document if your comments are more than 2000 characters long and/or you can provide your comment via video with a YouTube link.

FDA suggested two topics for comment. Consider including medicines you have tried – even if off-label – and their effects (positive, negative, no effect,side effects, intolerable side effects, etc.).

 

FDA Suggested 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.)

a. How does the condition affect your daily life on the best days and worst days?

b. What changes have you had to make in your life because of your condition?

FDA Suggested 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.)

a. What specific symptoms do your treatments address?

b. 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?

a. Have these treatments improved your daily life (for example, improving your ability to do specific activities)? Please explain.

b. How well have these treatments worked for you as your condition has changed over time?

c. What are the most significant downsides of these treatments (for example, specific side effects)?

Transcript Day I April 25, 2013 http://www.fda.gov/downloads/Drugs/NewsEvents/UCM354951.pdf

Transcript Day II April 26, 2013 http://www.fda.gov/downloads/Drugs/NewsEvents/UCM355406.pdf

 

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