Blog Profile / Eye on FDA


URL :http://www.eyeonfda.com/
Filed Under:Medical / Pharmaceutical
Posts on Regator:398
Posts / Week:1.4
Archived Since:November 3, 2010

Blog Post Archive

The Drop in OPDP Enforcement

Back when the Office of Prescription Drug Promotion (OPDP) issued regulatory action letters on a regular basis (either Warning Letters or Untitled Letters) regarding what the agency saw as infractions in the course of promotional speech, I would post a … Continue reading ?

More Space on Twitter – Does it Change Things for Pharma?

This week media carried reports that Twitter was going to making a shift in policy regarding space. Until now, you have been limited to 140 characters in your tweeting which included space for your – albeit tiny – URL and/or … Continue reading ?

Which Way on the Public Health Narrative on Zika?

Back in February in a post entitled “From HIV to Zika – The Role of Communications“, I listed several of the hallmark characteristics involving the communications environment and emerging pathogens, drawing not only on recent observations with respect to Ebola, … Continue reading ?

Weekly Roundup 4.29.16

Goodbye April. It was nice knowing you. There were a lot of noteworthy developments this week and I would like to write about them all, but as usual, will pick only a few from the bunch. FDA Issues Complete Response … Continue readi...

What Pharma’s Are Doing on Periscope – Update on the Landscape

If you have Periscope on your phone, you may find yourself doing something and all of a sudden, hear a little whistle that is the sound cue to let you know that someone you follow has gone live. I set … Continue reading ?

Weekly Roundup 4.22.16

A few weeks ago it was snow, now it is pollen – laden everywhere. Dogs, cars, outdoor seating, all covered in a fine yellow haze. Or is that me? I have had such a busy week that the result has … Continue reading ?

Weekly Roundup 4.15.16

It seems safe to say we are officially done with snow. Winter is finally at our backs. In the rear view mirror. Yes, we have shifted gears into that very, very short time of the spring – at least here … Continue reading ?

Serious Communications Planning Needed Now for Zika

Election cycle aside, it is going to be a rough summer. As things stand, this will likely become the summer of Zika as the country faces a growing potential for dealing with transmission inside the U.S. and abroad.  As the … Continue reading ?

Weekly Roundup 4.8.16

I put the herbs into the garden on a warm and balmy day last weekend only to fall victim to freeze warnings a day later so brought them in the house. Warms up. Put them back outside and then another … Continue reading ?

More or Less – FDA Press Releases 1st Quarter 2016

There are going to be times when FDA has less to say than at other times. In fact, there have actually been times where the agency has gone weeks without issuing a press release about anything. This quarter was not … Continue readin...

Weekly Roundup 4.1.16

The year is now officially one-fourth done. We have a long, hot summer to slog through that will no doubt be followed by a tumultuous autumn election cycle, so it is perhaps best now to take time and enjoy the … Continue reading ?

Once and Future AdComms Affecting Drug Applications

One area of FDA activity that I like to track is in relation to advisory committees which I think provide us with something of a surrogate marker for the pace at which FDA is considering and approving new drugs. To … Continue readin...

Weekly Roundup 3.25.16

Well the first quarter of 2016 has sure blown by. We had the earliest Equinox since the 19th Century. Someone flipped a switch and everything started blooming at once. The cherry blossoms got well underway this week. And here is … Continue reading ?

Patient Engagement Mainstreams

One Tuesday morning early in October in 1988, a large group of protestors appeared in front of the building that housed the Food and Drug Administration and effectively shut the agency down. There were hundreds of protesters present, organized by … Continue reading ?

Weekly Roundup 3.18.16

St. Patrick’s Day is behind us, Easter is before us. And yet, there is a forecast of snow for our area here in the mid-Atlantic looming before us for the weekend. Yes, it is that delightful time of the year … Continue reading ?

Testimonials – The Pitfalls

People like to get information from people they trust. Moreover, a hallmark of digital communications has been a turning away from large, institutionalized sources for information and turning instead to hear from individuals. Pew Research has shown that especially for … Continue reading ?

Weekly Roundup 3.11.16

The chives have poked their way up through the winter refuse of leaves and dried stems letting me know it is time to get the garden beds all ready again for Spring and to even be so optimistic as to … Continue reading ?

Socializing Medicine – FDA Enforcement Involving Social Media

Have you ever had a conversation with someone who said pharma needs to stay away from social media because it is too risky? Even today, some hold that opinion. When social media, used primarily by individuals in its nascent stage, … Continue reading ?

Weekly Roundup 3.4.15

2016 is speeding by. We are over two-thirds of the way through the first quarter. Mother Nature continues to taunt us. Daffodils were blooming this week, only to have snow accumulating around the blossoms today. Election fever runs rampant as … Continue reading ?

Promotion of Investigational Compound – Historical Overview

Communications regarding medicines in development – often referred to as “investigational compounds” can be particularly challenging. On the one hand, there are data milestones and advancements for the product through the regulatory cycle about which there is great interest. On … Continue reading ?

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