The FDA Drug Development for CFS and ME public workshop April 25 and 26, 2013

A Federal Register notice about the meeting will be posted on Monday March 11 (links at bottom of post). Here are some of the details.

 

To attend in person go to http://mecfsmeeting.eventbrite.com to sign up. You must sign up by 5pm EST Monday, 8 April 2013.

Required information

your name (first and last)

email address

affiliation (patient, advocate, name of organization, etc.).

 

The next part of the form asks if you (are a patient/patient representative and)want to be considered to present comments as part of the April 25th panel discussion on specified meeting topics.

 

If you indicated that you wanted to be considered, you are then asked which of the two discussion topics you want to address.

The topics are:

Disease Symptoms and Daily Impacts That Matter Most to Patients

Patients’ Perspectives on Current Approaches To Treating CFS and ME

 

Each topic will start with a panel discussion of patients and then there will be a facilitated discussion that all participants will be invited to take part in.

 

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?

 

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)?

 

It seems there will be additional public comment time (this will depend on how many requests there are). Probably the most helpful comments will be related to facilitation of and expediting development of safe and efficacious drug therapies for ME and “how to identify sound, quantitative outcome measures that can be used in clinical trials to determine whether disease symptoms improve with specific drug interventions”.

 

For those who cannot attend in person – the meeting will be webcast ( http://mecfsmeeting.eventbrite.com) and you can submit comment via www.regulations.gov (as of 9 March 2013 the docket for this meeting does not seem to be open yet )

 

In addition to the confirmation page on eventbrite, you will receive a confirmation email from United States Food and Drug Administration via <orders@eventbrite.com>. – Your confirmation email will include an order number (also on your confirmation page).

 

(The agenda isn’t out yet…)

 

Have you signed up to attend?

Which patient discussion panel are you interested in being on? Why?

Are you providing public comment?

Which topic will provide comment on? Why?

Will you watch the webcast?

Will you submit comment to the docket?

Which topic will provide comment on? Why?

 

Here is the Federal Register notice for “Drug Development for Chronic Fatigue Syndrome and Myalgic Encephalomyelitis; Public Workshop” the FDA meeting that will be held 25/26 April 2013

https://www.federalregister.gov/articles/2013/03/11/2013-05562/drug-development-for-chronic-fatigue-syndrome-and-myalgic-encephalomyelitis-public-workshop

this is the link to the pdf of the notice:

http://www.gpo.gov/fdsys/pkg/FR-2013-03-11/pdf/2013-05562.pdf

 

 

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