Drug and FDA News, July 2013
The big BIG reminder for the ME/CFS community is that the public comment docket on drug development for ME/CFS will close on August 2, 2013. As of this morning, there are only 201 comments! That’s disappointing, given that FDA said it received 750 comments regarding Ampligen. We should not let this opportunity slip by! Remember that you can submit written comments (including attaching a document) or a link to a YouTube video. Take a minute and submit your comment now.
Other FDA new items of interest:
- FDA is hosting a webinar on Draft Guidance to Industry on Developing Drugs for Rheumatoid Arthritis this morning at 11am. The webinar will be archived for later viewing. I’ll be watching to see what I can learn about FDA’s process of developing guidance for industry, since FDA has committed to doing so for ME/CFS.
- FDA is hosting a public meeting for patients, caregivers, and advocates on Demystifying FDA: An Exploration of Drug Development. The meeting is all day on September 10th in Washington, DC and it will be webcast. You do need to register in order to watch the webcast. The agenda has not been posted yet, but this should be a very educational meeting.
- One of the most common pain relievers is acetaminophen, available both by prescription and over the counter. FDA recently cautioned consumers about the dangers of taking too much acetaminophen. Before I found a pain management specialist, I took ibuprofen and acetaminophen over the counter for my pain and probably took too much on occasion since my pain was not being adequately treated. Just because something is OTC does not mean you can take large doses. And given the fact that ME/CFS patients take many drugs off label, we have to be especially careful about dosing and combination.