One month to go until the FDA’s Drug Development Workshop for ME and CFS! There is a boatload of information that might be helpful to you in preparing for the meeting, even if you will only be watching online. I’ll add to this list as more resources become available.
Meeting Materials
Draft agenda (pdf link)
FAQs about the meeting (pdf link)
How to Participate
If you want to speak at the meeting, comments are due April 8th
Register for the meeting and submit comments
Submit written comments to the docket (open until August 2, 2013) using the docket number FDA–2012–N–0962
The questions FDA would like patients to answer
Suggestions on what to focus on in your comments
Dr. Lily Chu and Dr. Leonard Jason’s survey
Register to watch the meeting by webinar
How FDA Evaluates Drugs
Drug Approval Process Infographic (pdf link)
CFIDS Association webinar: Overview of the Drug Development Landscape (March 28, 2013)
Patient Focused Drug Development Program
Designating ME/CFS as a serious or life threatening condition
Speeding up the process for drug approval
FDA’s webinar on advocacy and drug approval (November 2012)
FDA’s teleconference with ME/CFS patients (September 2012)
thank you for all this good material! — rivka
Thank you so much for laying this out for us. I’m printing it out.