Blog Profile / Eye on FDA

Filed Under:Medical / Pharmaceutical
Posts on Regator:362
Posts / Week:1.4
Archived Since:November 3, 2010

Blog Post Archive

Up Scope! Pharma, Periscope and Some Regulatory Questions

Back in June in a posting about the new (relatively) live streaming capability brought to use by Periscope. The app, acquired by Twitter prior to its launch early in 2015, allows you to live stream content from where you are to … Continue reading ?

Weekly Roundup 11.20.15

The cranberries have been bought and so have the clementines. The cream cheese for the pumpkin cheese cake is in the fridge along with the sausage and green apples for the cornbread stuffing. The turkey is on order for pickup … Continue reading ?

HIV Celebrity Diagnosis – What’s Changed. What Hasn’t.

On Monday news came out saying that actor Charlie Sheen would be announcing that he had HIV during a TODAY Show interview that would occur on Tuesday. In addition he issued an open letter about his announcement and HIV status. … Continue reading ?

Weekly Roundup 11.13.15

The leaves are falling in earnest and faster than they can be raked and packaged for pickup. The stomach craves comfort food. Thanksgiving goodies are just around the corner. This week FDA had a federal holiday (Veteran’s Day) while many … Continue reading ?

Weekly Roundup 11.6.15

Every year I am concerned that I will run out of Halloween candy. I never do. Every year there is some left over. Apparently this is my trick and my treat. We have had an unusual warm spell in the … Continue reading ?

Upward Mobility – The Great Migration Into Optimizing

One of the many noteworthy milestones with respect to digital has been around the transition to mobile search. As was recently reported, Google’s Amit Singhal speaking at a conference noted that Google is getting over 100 billion searches each month … Continue reading ?

Weekly Roundup 10.30.15

If you are like me, you have raided – at least once – the stash of candy you have squirreled away to give out this weekend. It happens every year. I am weak. Fortunately, tomorrow they will arrive and take … Continue reading ?

Weekly Roundup 10.23.15

There was no Weekly Roundup last week due to a confluence of circumstances, including the fact that it seemed a very quiet week last week when it comes to many of the things I watch. But this week, there was … Continue reading ?

A Look Back at Regulatory Enforcement by Therapeutic Category

In past years, I have always provided quarterly updates of the Warning and Untitled Letters that the Office of Prescription Drug Promotion (formerly DDMAC) puts out, regulating the promotion of pharmaceutical products. However, with only one letter issued each month … Continue reading ?

Advisory Committee – Vacancies and Transparencies

The FDA has a total of 33 Advisory Committees, 17 of which are focused on Drugs and 5 of which are focused on blood, vaccines and other biologics. For our purposes today, we are going to focus on those dedicated … Continue reading ?

Weekly Roundup 10.9.15

The days are growing noticeably shorter. The autumn chill has made itself felt from time to time. The leaves look ready to do their turn. The garden is in want of a mulching. Pumpkins are expectantly perched on front porches … Continue reading ?

FDA Needs a Communications AdComm

When it comes to communications, the environment has been fast, the FDA – slow. A few months ago I talked about a few of the potentially game changing implications of some relatively new platforms – Meerkat and Periscope, which allow … Continue reading ?

Communications + Medicine = Public Health – The WHO HIV Guidelines and the Role of Comms

Last August I wrote a posting about the important role of communications during the initial stages of an emerging contagious or communicable disease. But communications not only serves a vital purpose at the beginning of an epidemic, it also does … Continue reading ?

Weekly Roundup 10.2.15

Joaquin is a knock knock knockin’ at our door. While the government did not shut down due to a political crisis, it may not be clear that a weather crisis won’t do the job. Washington can always use a good … Continue reading ?

FDA Adds a New AdComm for Patients

This week FDA published a Federal Register announcement stating that the agency was establishing a new Patient Engagement Advisory Committee designed to provide counsel to the Commissioner on issues related to medical devices. The agency said that the scope is … Continue reading ?

Weekly Roundup 9.18.15

For those of us hungry for it, we had our first taste of autumn. It has been lovely to sleep with windows open. Granted the long shadows appear earlier than they used to and the sun is setting from a … Continue reading ?

Then and Now – Shutdown Showdown

The last time we faced a government shut down, there were some advance communications on how various government agencies were going to be operating during the “event”. Last time, the executive brand had issued a memorandum on September 17, this … Continue reading ?

Weekly Roundup 9.11.15

Today we remember those lost, honor those living who were there to help and dedicate ourselves to a goal of peace. Here is a bit of what happened this past week that I thought noteworthy: NIH Announces Landmark Blood Pressure … Continue reading ?

More on Twitter and Pharma

Before breaking for summer vacation, I had posted about the increase in Twitter followers among pharma companies this year over last and noted that the overall number of Twitter followers of pharma feeds had increase significantly. That was true despite … Continue reading ?

Weekly Roundup 9.4.15

I missed the Weekly Roundup last week while on vacay and took this week off from blogging because let’s face it, everyone is gone. We are at that special cusp when the calendar really does coincide with a noticeable change … Continue reading ?

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