Index of FDA Meeting Resources

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

FDA’s meeting materials page

Draft agenda (pdf link)

Why this meeting is important

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

CFIDS Association survey

Dr. Lily Chu and Dr. Leonard Jason’s survey

Register to watch the meeting by webinar

How FDA Evaluates Drugs

FDA’s Drug Approval Process

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)