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Blog Profile / Eye on FDA


URL :http://www.eyeonfda.com/
Filed Under:Medical / Pharmaceutical
Posts on Regator:340
Posts / Week:1.7
Archived Since:November 3, 2010

Blog Post Archive

Weekly Roundup 9.26.14

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...

Here Comes the Sun – Communications Tips on The Sunshine Data Publication

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 ?

Weekly Roundup 9.19.14

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 ?

Talking Points for When People Who Don’t Get Social Media as a News Platform

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 ?

Weekly Roundup 9.5.14

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 ?

Tracking 10 Healthcare Beat Reporters on Twitter

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 ?

FDA Looking for New Head of CDER Communications

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 ?

Weekly Roundup 8.22.14

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 ?

DTC and Regulatory Enforcement

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 ?

Cloudy Forecast on Sunshine Act Data Release?

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 ?

Weekly Roundup 8.15.14

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 ?

Weekly Roundup 8.7.14

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 ?

To Tweet or Not to Tweet? Or Even Retweet? FDA, Tweeting and Twitter

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 ?

Upcoming AdComms By Subject Matter

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 ?

Weekly Roundup 7.25.14

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 ?

Developing a Policy for Correcting Third Party Misinformation

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 ?

Weekly Roundup 7.18.14

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 ?

Collection of FDA and Social Media Resources

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 ?

Weekly Roundup 7.11.14

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 ?

FDA Untitled Letter for a Sponsored Link and a Webinar: In More than 140 Characters: FDA’s Social Media Guidance – Past, Present and Future

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 ?

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