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Blog Profile / Eye on FDA


URL :http://www.eyeonfda.com/
Filed Under:Medical / Pharmaceutical
Posts on Regator:333
Posts / Week:1.7
Archived Since:November 3, 2010

Blog Post Archive

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 ?

FDA Press Releases – What They Say – First Half 2014

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 ?

Weekly Roundup 7.4.14

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 ?

Weekly Roundup 6.27.14

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 ?

How a Watch Can Result in More OTC Switches

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 ?

Guidance on Two Social Media Fronts from FDA’s OPDP

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 ?

Join Me for a Webinar – Communications Implications of the Sunshine Act Data

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 ?

Weekly Roundup 6.13.14

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...

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