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Author Archives: Jennie Spotila
Speeding Things Up
In my previous post, I explained the definitions FDA used to determine that CFS is a serious or life-threatening condition. But the true significance of FDA’s decision is that it makes CFS treatments eligible for programs that speed up the … Continue reading
Posted in Advocacy
Tagged biomarkers, CPET, DHHS, drugs, exercise, FDA, government, life-threatening, post-exertional malaise, serious, treatment
1 Comment
Serious Or Life-Threatening
During the stakeholder teleconference with FDA on September 13, 2012, Dr. Sandra Kweder said that FDA considers ME/CFS to be a serious or life-threatening condition. In the world of FDA regulations, this is a very important designation. Here’s the full … Continue reading
Posted in Advocacy
Tagged DHHS, drugs, FDA, government, life-threatening, living with, politics, risk, serious, treatment
4 Comments
FDA Webinar on Advocacy
Yesterday, the FDA hosted a webinar for the ME/CFS community on “Working Together for Change.” Their stated goal was to show what has been successful for patient groups in the past in working with FDA and other entities. The slides … Continue reading
Posted in Advocacy
Tagged advocacy groups, approval, CDER, DHHS, drugs, FDA, government, politics, treatment
12 Comments
CFSAC Testimony of Dr. Joan Grobstein
Dr. Joan Grobstein delivered these comments to the CFS Advisory Committee at its October 3-4, 2012 meeting. She has kindly given me permission to publish them here. Hello. I’m Dr. Joan Grobstein. I’m a physician. My topic is responsibility. Recently … Continue reading
Posted in Advocacy
Tagged case definition, CDC, CFSAC, DHHS, funding, government, politics, speaking out, testimony
4 Comments
Puzzle Pieces
Let’s play a game. Imagine you have a large puzzle that makes an Impressionist picture of a colorful cottage-style garden. You can put it together as long as you have the picture on the box. First you assemble the lower … Continue reading →