We’ve had a good discussion in the comments on the advocacy action to request another meeting with FDA. I asked FDA if they would be pursuing Guidance to Industry on ME/CFS drug development, and was told it is already underway. I updated the original post with the email response from Dr. Theresa Michele.
There are a few other FDA news items to share with you:
- FDA has just issued Draft Guidance for Industry on Expedited Programs for Serious Conditions – Drugs and Biologics (pdf lnk). This Guidance contains FDA’s policies and procedures on the four programs for expedited review: Fast Track, Breakthrough Therapy, Accelerate Approval and Priority Review. This document is of great interest to ME/CFS advocates because as a serious condition, drugs for the treatment of ME/CFS may be eligible for one or more of these programs. Public comment on this draft guidance is due August 26, 2013.
- This blog post from Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research, describes the newest expedited review program: Breakthrough Therapy.
- This blog post from Richard Klein, Director of the Office on Health and Constituent Affairs, mentions the ME/CFS Patient Focused Drug Development workshop and briefly mentions several other meetings held in June.
- On July 29, FDA is hosting a scientific workshop to discuss the opioid conversion tables included with opioid medications. These tables are used to help switch patients from one opioid medication to another. The meeting will convene experts to determine what, if anything, needs to be done to improve conversion practices.
- DON’T FORGET: The public comment docket for the ME/CFS Drug Development meeting closes on August 2, 2013. If there is something you think FDA needs to know about drug development for ME/CFS, please take a few minutes to post your comments to the docket.