This webinar is about the Draft Guidance to Industry on Drug Development for ME/CFS (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM388568.pdf)
The webinar will have some Q&A time – so make submit your questions.
“Guidance Webinar Online-Access Instructions:
To access this webinar, follow the link provided below. Audio will broadcast from your computer speakers.
After following the link, enter as a guest and provide your FULL NAME and organization (i.e. “John Smith – FDA/CBER”). The host will then allow you to enter. If you experience technical difficulties email Jeffery.Rexrode@fda.hhs.gov for assistance. Closed captioning will be provided. Questions/Comments can be submitted live via a Q/A chat window.”
In your public comment on the Draft Guidance (due 12 May 2014), consider including the positives in the guidance as well as concerns you may have.
Submit your written comments to the docket (Docket No. FDA-2014-D-0264 ) http://www.regulations.gov/#!searchResults;rpp=25;po=0;s=FDA-2014-D-0264;fp=true;ns=true