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Blog Profile / Eye on FDA

Filed Under:Medical / Pharmaceutical
Posts on Regator:324
Posts / Week:1.7
Archived Since:November 3, 2010

Blog Post Archive

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...

Warning and Untitled Letters By Therapeutic Category – Oncology

Ever since developing a data base on the Office of Prescription Drug Promotion (OPDP) Warning and Untitled letters, I have wanted to sort the information along various lines to see differences and similarities given different circumstances.  Last year, I produced … Continue reading ?

Weekly Roundup 5.30.14

This is just awful.  A whole week without a posting.  Not because I did not have anything to talk about, but because I did not have anything like time on my side.  It was one of those weeks.  I did … Continue reading ?

Weekly Roundup 5.23.14

We were all feeling a little pent up this Winter and delighted to see Spring.  And what is more delightful than seeing others delighted?  Check out the Weekly Roundup video of dairy cows greeting the meadow after a winter in … Continue reading ?

Media, Science and Emerging Pathogens – Communications in a Time of Outbreak

Accuracy and consistency in communications is always important.  On important issues, misinformation can lead to serious consequences.  That is especially true in the field of public health. In watching the media coverage of the outbreak of  Middle East Respiratory Syndrome … Continue reading ?

Weekly Roundup 5.16.14

The Weekly Roundup is late after a much-needed day of respite.  Sorry about that.  A little bit of Spring Fever mixed with a lot of need to catch up on things around home. In any case, there is a little … Continue reading ?

Looking Beyond Patient Engagement for Pharma and Social Media

As we wait for the anticipated guidance from FDA regarding the use of social media by the pharmaceutical industry, one of the many aspects discussed as been that of patient engagement with the industry.  The Internet is highly utilized for … Continue reading ?

Weekly Roundup 5.9.14

Spring lasted about 20 minutes. It was very cool and rainy. Then it was sunny and temperate. Now, temperatures in the 90s are predicted for early next week.  Spring was sort of short, but it was lovely. The azaleas are … Continue reading ?

Emerging Viral Outbreaks

Last Friday, May 2, at around 3 PM, the Centers for Disease Control and Prevention (CDC) in Atlanta held a press conference about the first detected case in the United States related to the coronavirus known as Middle East Respiratory … Continue reading ?

Weekly Roundup 5.2.14

I need a bear hug from Friday. April showers.  We had a lot of them.  Some of them, as you know, were snow showers.  This week, in particular, saw buckets of rain in many areas of the country – sometimes … Continue reading ?

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