While I’m waiting for the ISGIO meeting to start in Philadelphia, I just noticed that the FDA announced draft guidelines for REMS programs see the link here : http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf
I’ll add a clickable link later as this is being posted quickly from my iPhone. The important thing is that these guidelines are being announced several years after they have been running, so I think we can reasonbly assume the same thing will happen with social media guidelines.
The upcoming open town hall meeting to gather public opinion is therefore likely to be just that, information gathering. Guidelines will follow in a couple of years after some reflection and negotiations internally.