|Filed Under:||Medical / Pharmaceutical|
|Posts on Regator:||269|
|Posts / Week:||1.7|
|Archived Since:||November 3, 2010|
In my data base of Office of Prescription Drug Promotion (OPDP) Warning and Untitled Letters issued during the years 2004-2013, one of the many fields I track is, of course, the type of violations that were incurred. There are many, … Continue reading ?
Pulling on my database on Warning and Untitled Letters over the past ten years, I had occasion to look up those violations over the past 10 years that involved the spoken word. The database profiles each letter and tracks various … Continue reading ?
As many of us get ready to hit the road this week to spend the holiday with friends and family during this season when we give thanks and take stock of our many blessings, I will voice one now. Thanks … Continue reading ?
Many people this week are disappointed, chagrined even, to realize that Thanksgiving is not next week. Well, if not many, then me. Seriously, it is very late this year….and it is my favorite holiday. Still, I am somewhat grateful for … Continue reading ?
My data base on warning and untitled letters now includes the years 2004-today. It includes 282 letters covering a neat total of 1000 different violations. When I was working on it earlier, I did a post looking at letters aimed … Continue reading ?
Oh dear. I originally dated this Weekly Roundup as being in 2011. That is the kind of week it has been – I’m not even sure what year it is. The time of year, however, is obvious, with multi-tinted leaves … Continue reading ?
I just got the new iPhone. As I retired my old one, it went into a drawer with several smart phone predecessors. I also enjoy my iPod touch and my iPad is always within reach – always. However, my brother-in-law … Continue reading...
We are in the last two months of 2013. Because in my head it is still 1997, I find this hard to wrap my head around. But not even a government shut down makes time stand still. It is November … Continue reading ?
Back in 2011 when Google+ emerged from Beta and started offering branded pages, there was a good deal of commentary in the blogosphere about the potential use for the new platform by pharma – even here at Eye on FDA. … Continue reading ?
Well, there is definitely a bite of autumn crispness in the air and I think we are on the verge of first frost. The days are noticeably shorter. Daylight savings (always thought it a funny name for it) is upon … Continue reading ?
Government shut down or no government shut down, the read for Warning and NOV letters out of the Office of Prescription Drug Promotion (OPDP) is slim pickings. It is always a good idea at the end of the quarter to … Continue reading...
For Washington, it is real quiet. This week on my way to work while driving past the Lincoln Memorial, there was a man with a lawn mower unofficially mowing the lawn. The Federal Register which reports on all of the … Continue reading ?
People are looking for black and white answers about what government agencies in general are going to do during the shutdown respecting specific operations. One of the specific areas of interest at FDA has been whether or not there will … Continue reading ?
In July 2011, FDA issued a draft guidance on Medical Apps that set out the agency’s approach to regulate apps – even as thousands of such apps were being developed and downloaded by users. Just over two years later in … Continue reading ?
It would seem like an obvious challenge to write for a blog called Eye on FDA when in fact, there is a government shutdown. That said, an agency that regulates one-quarter of the U.S. economy does not come to a … Continue reading ?
While not a news breaking blog, when interesting and timely information comes my way – it is for the sharing. This from my colleague Kip Piper of The Piper Report. This is, of course, in the event that the Congress … Continue readi...
What’s to round up during a week when there is a government shut-down and most FDA staff are off? Well, not much, but I will go over a little and provide some thoughts about next week. But first, remember a … Continue reading ?
On September 17, 2013, the Office of Management and Budget (OMB) sent out a memo advising federal agencies to begin preparing for a government shutdown. Once again, as in the Spring of 2011, we are faced with the question of … Continue reading ?
Autumn officially arrived, but it seemed as if we have had a preview for the past several days. Once September began, the light began to take on a completely different effect, particularly at the end of the day. The mums … Continue reading ?
Always so sad to part with my seersuckers, the linens and the white bucks rounding them up and putting them in the barn for their long slumber until Memorial Day of 2014. Where did the time go? To console me, … Continue reading ?