|Filed Under:||Medical / Pharmaceutical|
|Posts on Regator:||340|
|Posts / Week:||1.7|
|Archived Since:||November 3, 2010|
I bring you the Weekly Roundup today from Cape Cod where there is a lovely sense of autumn in the air, but blue skies and lovely shoreline allowing us to still remember the summer’s most pleasant days. And here is … Continue reading...
The Sunshine Act will peek out from behind some, but not all, of the clouds on the horizon soon, leading to a new day in transparency on payments between the medical products industry and those who provide care. Data will … Continue reading ?
Argh! It is International Talk Like a Pirate Day! Fear not Matey! I’m not gonna write my whole posting in pirate-speak, though it be a tempting morsel to ponder. There were lots of approvals this week and finally a wee … Continue reading ?
Someone asked me the other day something to the effect of this – what is the point of social media when it comes to news – isn’t CNN just as fast? It occurred to me that many of us in … Continue reading ?
After a surprisingly mild August, September begins with summer in full force – heat, humidity and a mosquito rally that is immensely annoying. Forecasts however predict that we only have one more day of this and then a break to … Continue reading ?
It is not news that social media has fundamentally changed the way we communicate. Today, we share news, we don’t just read it. A news cycle is every moment of every day. We rely on people to pitch news to … Continue reading ?
For those who have had the pleasure of working with Julie Zawisza in the past, the news is that she has moved on to a new role at FDA. That means her former position in communications at the Center for … Continue reading ?
For the past few years here in Washington, the summer ended in August seemingly with the flip of a switch following Labor Day Weekend. The daily threat of storms abated, the high humidity retreated, air conditioners were switched off in … Continue reading ?
FDA’s OPDP views nearly all industry communication – whatever the venue and intent – through a lens of advertising. Certainly a big focus of regulatory enforcement has been direct-to-consumer advertising and for a long time, there has been guidance available … Continue reading ?
In June I put on a Webinar about the communications impact and considerations respecting the upcoming release of data from CMS under the terms of the Sunshine Act. That followed a blog posting from April. The point in both of … Continue reading ?
It is hard to believe that I see on Facebook many of my friends who are parents talking about their kids headed back to school this week. Back to school? Back to school? Why when I was a lad, which … Continue reading ?
August is supposed to be slow. And lazy. Laying around doing nothing. That is what Marky the Cow is doing in this picture. (For those of you who are new to Eye on FDA, Marky is a dairy cow in … Continue reading ?
On June 27, FDA approved a new product – a rapid acting inhaled insulin indicated for the treatment of diabetes call Afrezza. The agency announced the approval by sending out a press release. The agency also sent out this tweet: … Continue reading ?
In February and in April I posted a listing of upcoming advisory committees by subject matter and people seemed to like this way of looking at it, so I try to repeat it every so often. Today is every so … Continue reading ?
We sit on the cusp of August – the month when America goes on vacation. Everything will slow down, rush hour will be less rushed, lawns will need less cutting and in our sights is Labor Day which brings the … Continue reading ?
Last week I held my Webinar on FDA’s Regulation of Social Media called “In More than 140 Characters…” During the 1 hour presentation, I attempted to cover a lot of ground, wanting not only to focus on the latest two … Continue reading ?
Well, the “poor man’s polar vortex blew through and frankly, while it did make life overall more bearable. But the dogs, the lawn and the flowers all seem happier so that makes it ok by me. I also had my … Continue reading ?
Many years have passed since FDA began attempting to enunciate a regulatory approach to digital and social media – beginning in 2009 and still presumably on-going. In June the most substantive guidance yet was released by the agency addressing two … Continue reading ?
As we head into the weekend after a busy week, with at least part of the country being informed about significantly cooler temperatures for next week being termed the “poor man’s polar vortex” of the summer – news, if not … Continue reading ?
I crammed a lot into that title. But here is the skinny. A few weeks ago, FDA issued some new guidances around social media. This week, (yesterday) an untitled letter was posted about a sponsored link - the subject matter … Continue reading ?