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Training and Strategy Mtg. for FDA Workshop

Nielk

Senior Member
Messages
6,970
Can one send in written testimony without actually being able to attend the meeting?
 

Ember

Senior Member
Messages
2,115
Can one send in written testimony without actually being able to attend the meeting?

As posted by Bob, Monday is the deadline for written comments to receive consideration:
Comments: Submit either electronic or written comments by April 8, 2013, to receive consideration. Submit electronic comments to www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document*. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Electronic or written comments will be accepted after the meeting until August 2, 2013.

* The relevant docket number is:
FDA-2012-N-0962-0004
Submit a comment: http://www.regulations.gov/#!submitComment;D=FDA-2012-N-0962-0004
 

Ember

Senior Member
Messages
2,115
On the government sites soliciting comments, I notice that two different deadlines have been posted, one for Sunday night and the other for Monday night:

http://www.regulations.gov/#!documentDetail;D=FDA-2012-N-0962-0004
Comment Now! Due Apr 07 2013, at 11:59 PM ET
http://www.regulations.gov/#!docketDetail;D=FDA-2012-N-0962
Comment Now! Due Apr 08, 2013 11:59 PM ET

Only 86 comments have been received so far. Those seem to include comments pertaining to last September's teleconference.
 

Ember

Senior Member
Messages
2,115
I'm not sure why the docket page is saying April 8th, but August 2nd is the real date.
Here again is the relevant quotation:
Comments: Submit either electronic or written comments by April 8, 2013, to receive consideration. Submit electronic comments to www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov. Electronic or written comments will be accepted after the meeting until August 2, 2013 (emphasis added).

The same government document invites comments by midnight on April 7, however:
Comment Now!
Due Apr 07 2013, at 11:59 PM ET
 

usedtobeperkytina

Senior Member
Messages
1,479
Location
Clay, Alabama
PANDORA Org and NAAME will be hosting another FDA Workshop Training and Strategy meeting on line at 1 p.m. on April 16. We are providing tips for making successful in-person or written comments to the FDA, the panelists and others attending the ME/CFS Drug Development Workshop. These tips are based on the experience of long-time advocates and suggestions from a drug development researcher.

Please sign up through this form, and we will send you an invitation to attend the April 16 meeting: https://docs.google.com/forms/d/1CmFksURXKE8P-ESc958XoNfFKMe9P9ByjeWheavMd80/viewf
The first 25 who sign up will receive the invitation.

Thanks
 

Nielk

Senior Member
Messages
6,970
PANDORA Org and NAAME will be hosting another FDA Workshop Training and Strategy meeting on line at 1 p.m. on April 16. We are providing tips for making successful in-person or written comments to the FDA, the panelists and others attending the ME/CFS Drug Development Workshop. These tips are based on the experience of long-time advocates and suggestions from a drug development researcher.

Please sign up through this form, and we will send you an invitation to attend the April 16 meeting: https://docs.google.com/forms/d/1CmFksURXKE8P-ESc958XoNfFKMe9P9ByjeWheavMd80/viewf
The first 25 who sign up will receive the invitation.

Thanks

The link doesn't work for me.
 

jspotila

Senior Member
Messages
1,099
Update: FDA has agreed to accept video testimony in the form of YouTube links submitted through the comment docket.

Many advocates had hoped FDA was going to accept video comment at the meeting, but FDA declined. In subsequent exchanges with FDA, I emphasized that the most severely ill patients cannot attend the meeting next week and that their views on the worst symptoms and the treatments they have tried were critically important. Personally, I believe it is important for the patients to be seen by policymakers to whatever extent is possible.

Based on feedback that I and others provided, FDA has agreed to accept and review videos submitted through the docket. If you wish to do this, make a video of yourself and post it to YouTube. FDA has asked people to focus on answering the questions FDA posed in the meeting notice as these will be most helpful to FDA in evaluating drugs moving forward. After you have posted the video to YouTube, you may submit the link through the comment docket. The deadline is August 2nd, so you have time to do this at your own pace.
 

Ember

Senior Member
Messages
2,115
Update: FDA has agreed to accept video testimony in the form of YouTube links submitted through the comment docket.
Would this video of an ME patient's best day be of interest to the FDA?

During the workshop, a panel of patients and patient representatives will provide comments to start the discussion on 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 symptoms? (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?
Could reference to this UK portrayal of severe ME symptoms and daily impacts prove useful?
 

jspotila

Senior Member
Messages
1,099
Jessica's videos are very powerful. She could certainly submit them in the docket. I don't think others should do that on her behalf, though.

FDA is most interested in answers to those questions in the meeting notice. There are a variety of ways people can answer them in their videos or written comments. Sticking to those topics will have the biggest productive impact on FDA's review of the docket and subsequent meeting report.