Blog Profile / Eye on FDA


URL :http://www.eyeonfda.com/
Filed Under:Medical / Pharmaceutical
Posts on Regator:333
Posts / Week:1.3
Archived Since:November 3, 2010

Blog Post Archive

Preparing Ahead – When Events Overtake Communications

Sometimes events present us with a seismic shift in the environment. And often when that happens, we have to have new language to describe the altered terrain. Inevitably there are gaps in our understanding. Familiar frames of reference become obsolete. … Continue reading ?

Weekly Roundup 7.31.15

It is the end of July! Even though childhood is far away in my rear view mirror, my year is still defined by the school calendar and I find myself lamenting a bit that the summer is already two-thirds over. … Continue reading ?

Weekly Roundup 7.24.15

Greetings from Texas. Late with the Weekly Roundup here due to some serious travel obligations which are still underway and afford me very little in the way of access to the Internet. Apologies.  Had it been a low news-level week, … Continue reading ?

FDA Press Releases – First Half of 2015

As regular readers may remember, I have started a database that tracks FDA press releases that goes back through 2014 and provided an overview of the 2014 press releases (See – FDA Press Releases – What They Said and How … Continue reading ?

Weekly Roundup 7.17.15

It was a wickedly busy week so apologies for the paucity of postings. We are over the half-way  mark for the year – if the year were represented by the days of the week, it would be Wednesday. Summer school … Continue reading ?

Weekly Roundup 7.10.15

Here in the mid-Atlantic, we are experiencing daily rains. Not just rains. Biblical deluges. The gardens are happy. The dogs are not. Meanwhile, while FDA seems rather slow, there is news – breaking news even – and here is a … Continue reading ?

A “Long Shot” at Getting FDA Off the Dime on Social Media

Last month, Politico reported on the communications aspects of the 21st Century Cures Act (the Act) – also known as H.R. 6 – the sweeping legislation that addresses a range of issues related to medical research and access to medicines. … Continue reading ?

FDA Enforcement of Digital Communications – An Update

In 2013, I published a white paper called “FDA Communications Oversight in a Digital Era” that drew upon the data base I had put together of OPDP Warning and Untitled Letters (referred to collectively as “regulatory action letters”). The object … Continue reading ?

Weekly Roundup 6.19.15

No postings this week – sorry about that – travel and business, but will shoot for some good ones next week. This was another week of tropical rain – the kind that comes and dumps steady water as if a … Continue reading ?

Weekly Roundup 6.12.15

It is as if the calendar just knows when to turn up the heat. We have crossed over into the second week of June and already we face days that head into the 90s and late afternoon thunderstorms that characterize … Continue reading ?

Live Streaming – Game Changer for AdComms and Beyond?

This week there was a lot of talk about last week and the meeting of the American Society of Clinical Oncology annual meeting ASCO 15, which was the 51st annual meeting of the society held May 29 – June 2 … Continue reading ?

Weekly Roundup 6.5.15

It has been a week of rain and gloom in our nation’s seat of government. It has been cold, gray and unpleasant. Commutes are nasty. The lack of sunshine is getting serious. But on the bright side, pollen has been … Continue reading ...

Regulatory Considerations in Optimizing a Site for Mobile

Fact: One of the primary uses of the Internet is to seek health information. Fact: By 2015, nearly two-thirds of Americans now have a smart phone; Fact: Of those owning a smart phone, 62 percent have used their phone in … Continue reading ?

Weekly Roundup 5.29.15

In spite of the fact that summer does not officially begin until the Summer Solstice which will occur on Sunday, June 21, if you are like me and many others the unofficial beginning of summer happens on Memorial Day. And … Continue reading ?

Advisory Committee Track Records

Needless to say, every time a product goes before an FDA Advisory Committee (AdComm), there are circumstances that make the deliberations that occur during that meeting a unique experience. A specific investigative compound being studied for a specific indication with … Continue reading ?

Weekly Roundup 5.15.15

Today is one of those days where if you took the date and read it backwards – 5.15.15, it would still be the same date and it has pretty much been that way all week. 5.14.15, 5.13.15 and so on. … Continue reading ?

The Guidance that Dare Not Speak Its Name

In December 2014, Commissioner Hamburg announced a proposed change in the FDA’s long-standing policy regarding blood donations from gay men – See “FDA Commissioner Margaret A. Hamburg’s statement on FDA’s Blood Donor Deferral Policy for Men Who Have Sex With … Continue reading ?

Weekly Roundup 5.8.15

It is one of my three favorite times of year – the days are so much longer – the evenings cool and pleasant for sleeping near open windows – the mornings crisp and the afternoons languidly warm. Flowers abound. There … Continue reading ?

Weekly Roundup 5.1.15

Happy May Day! As much of the world celebrates the worker, here we toil to bring you this week’s latest. We are well into the second quarter of the year – hard to believe – and are having those kinds … Continue reading ?

FDA Press Releases – 1st Quarter 2015

Last year I began a new database that tracks the press releases of FDA as a way to see what news the agency is talking about and provided a year end look at 2014. Looking back at the quantity and … Continue reading ?

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