It is the end of July! Even though childhood is far away in my rear view mirror, my year is still defined by the school calendar and I find myself lamenting a bit that the summer is already two-thirds over. And the summer has been anything but relaxing – a heavy travel week meant no postings in-between the Weekly Roundup. Hopefully this coming week will provide more opportunity.
While last week was busy at FDA, this week the summer has dialed down the clock.
In the meantime, here is a bit of what happened:
- Non-surgical Device for Obesity – FDA announced approval of a new device to treat adult obesity. It is aptly called the ReShape Dual Balloon System and it works by taking up space in the stomach to lead one to the sensation of being full. The device is inserted through an endoscopic procedure with the patient under mild sedation and the balloon is inflated after insertion with a sterile solution and patients are advised to pursue a diet plan to supplement. The device is indicated for adults with a BMI between 30 and 40 who have an accompanying obesity-related condition such as high blood pressure, high cholesterol or diabetes. The device is manufactured by a company specializing in non-surgical weight loss also called ReShape.
- AdComm Schedule Dries Up – It has been my observation that there are normally a lot of advisory committees on deck that are slated to happen at almost any given time. By my count there have been 19 advisory committee meetings so far this year. But if you look on the current FDA Advisory Committee calendar you will see that there are NO meetings schedule for August and only two in September. Right now, that’s it. It is just THAT slow of a summer.
- Cilantro Import Ban – And speaking of summer – a slightly uncharacteristic note for Eye on FDA – but since we use it a lot in summer (and it is one of my favorites) – it seemed worth noting that the agency this week issued an import alert regarding some cilantro from Mexico. News coverage provides further detail.
- SocialMedia.org Meeting – And in case you are going to be at the member meeting next week of SocialMedia.org being held in Washington on August 4-5, I hope you will come to my presentation. The meeting topic is “How Government Affect Social Media at Big Brands” and I will be joined by the Federal Trade Commission, the National Labor Relations Board, the Securities Exchange Commission, the White House and more. Three guesses what I’m talking about! #fdasm
That’s it for me this week. Have a good weekend everyone.
