Category Archives: FDA Policy

FDA Needs Communications Expert Support

On October 3, FDA’s Center for Devices and Radiological Health (CDRH) issued a press release entitled “FDA outlines plans for an outside network of scientific experts“.  The release states that the purpose of the effort is to “plan to create … Continue reading

Posted in FDA Policy, New and Social Media | 1 Comment

FDA Making Transparency Increasingly Clear

This week a number of people took note when the FDA announced the issuance of a report that outlined eight new proposals to increase transparency by allowing greater access to the agency’s compliance and enforcement data.  The eight proposals are … Continue reading

Posted in Advisory Committee Prepapartion, FDA Policy | Comments Off

Reflections on an Abyss – the Facebook Policy Change

Remember when the calendar was turning to the year 2000 and there was a great hand-wringing going on about whether or not Y2K would bring a digital meltdown?  And then the clock ticked, and it didn’t? One was reminded of … Continue reading

Posted in FDA Policy, New and Social Media, Warning Letters | 1 Comment

An Overview of FDA’s Utilization of Digital Media

Between earthquakes, hurricanes and the end of summer when everyone seems away on vacations to the beach, the mountains or somewhere in between, I decided to take a little hiatus for the last two weeks of August.  Labor Day behind … Continue reading

Posted in FDA Policy, New and Social Media | 3 Comments

D-Day for Pharma and Facebook

It is another one of those questions – how did we get here?  For months FDA’s DDMAC did not seem to understand the impact of social media, then asked for help understanding how to regulate it, then failed to produce … Continue reading

Posted in FDA Policy, New and Social Media, Podcast | 3 Comments