|Filed Under:||Medical / Pharmaceutical|
|Posts on Regator:||331|
|Posts / Week:||1.7|
|Archived Since:||November 3, 2010|
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 ?
From time to time, I field questions centered around FDA press releases and what they say. Every time I would have to go hunt and peck through years of releases to get an answer. Eventually I just put them into … Continue reading ?
Happy Independence Day for America. This week also so Canada Day. So while a week where work productivity may have dipped, enjoyment factors probably drove up – at least in North America. The season is marked by hot, humid days … Continue reading ?
Well, I am late again with the Weekly Roundup and I once again seek forgiveness. I didn’t even get much time to tweet! It has been a rowdy few weeks and the summer is shaping up to be unruly. We … Continue reading ?
Remember when your phone was just a phone? You flipped it open and made a call. It also may have told you the time, but you primarily used it for talking to people. Today you actually use it in ways … Continue reading ?
For four and half years now FDA’s OPDP has endeavored to devise answers to 5 questions raised during a public hearing on the Internet, Social Media and Pharma and Device Manufacturers held in April 2009. Finally, on a day when … Continue reading ?
I don’t usually do adverts here on the blog – in fact never, but you may remember a posting I did a few months back on the communications implications of the Sunshine Act implementation. There is room to be expansive … Continue reading ?
It is hot. It is humid. Mosquitoes have begun to make their presence known. Thunder and rain showers occur almost daily. Summer is truly here. And we are making our way rapidly to my favorite day of the year – … Continue readin...