FDA’s decision making process is complex, to say the least. But the more we can learn about the process and how FDA fulfills its mission, the better equipped we will be to participate meaningfully in the upcoming Drug Development Workshop for ME/CFS. Fortunately, there are a variety of resources to help us out.
FDA is hosting a webinar entitled “FDA 101” to help educate the ME/CFS community about FDA’s basic functions and regulatory framework. The webinar is scheduled for April 18th at 3pm Eastern, and you need to register in advance.
The CFIDS Association recently hosted two webinars about FDA. The first was an overview of the drug development landscape, and explained the pipeline from lab discovery through clinical trials and into commercial use. The second explained the intricacies of the phrase “safe and effective treatment for ME/CFS,” and its relevance in the context of the upcoming FDA Workshop (recording should be available soon). Recording is now available.
I’ve gathered other materials relevant to the Workshop in a single post. I’ve also written about FDA’s goals for the meeting, and why the meeting is so important. There are also other resources for consumers available on the FDA’s website.
Whether you are attending the Workshop or watching online, take some time to watch one of these webinars or read more about FDA’s approval process. The more we know about how treatments are created and approved, the more effectively we can advocate for the swift development of such treatments for ME/CFS.