Regulatory

The Sunshine Act and digital products: what you need to know

The Physician Payments Sunshine Act ("Sunshine Act") is coming into effect August 1st and pharmaceutical companies will be require...

FDA and social media guidance (for real this time)

This interview with Thomas Abrams in Pharmalot discusses the FDA's position on its promised social media guidance is actually real...

Regulated social media - are you obligated? responsible? liable?

Short answer: yes. More detail available in the blog post......

Analysis of OPDP letters and digital channels

The folks at Eye on FDA have released a new report on letters issued by the Office of Prescription Drug Promotion (OPDP) relating ...

New regulatory tool: the "FDA Advisory Bouquet"

The FDA has decided to do away with warning letters for social media issues, instead they have developed a new tool called the "FD...

Three days of hearings on the FDA's regulation of "Mobile Medical Apps"

A congressional hearing on the FDA's regulation of mobile medical apps wrapped up on the 21st (video of the final day is available...

FTC dotcom guidelines follow FDA tacit rules

The FDA and the FTC are related but distinct. As advertisers of healthcare products we need to be on top of what both groups say o...