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Senak
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That is an interesting question. Im assuming that it is sending product to the U.S.
Commented May 17, 2010 on Anatomy of a Consent Decree at Eye on FDA
Anatomy of a Consent Decree
Following yesterday's posting about catching up, another thing that happened last week is that a Consent Decree was issued by the FDA. The company involved was Shelhigh, Inc., which produces implantable devices. First of all, what is a Consent Decree? It is an agreement between the FDA and a ...
Sorry to disappoint. I actually didnt see it, but I was in Berlin most of the week and actually was playing catchup today. Thanks for the heads up though. Best, M
Commented Apr 2, 2010 on Weekly Roundup - 04/02/10 at Eye on FDA
Weekly Roundup - 04/02/10
The daffodils are expressing their buttery flavored confidence; tulips look robust and ready to pop; the garden beds are mulched and the deck newly stained. The barbeque pit is cleaned and pansies reside in all of the flower boxes boasting the multiple colors of a crayon box. Yes, Spring is...
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Mar 15, 2010
Obviously, we dont agree. :)
Commented Mar 9, 2010 on Facebook and Web Pages - What Pharma and FDA Need to Know at Eye on FDA
Facebook and Web Pages - What Pharma and FDA Need to Know
Recently, people have noticed an important milestone. The top traffic referral site is .... Google? Nope. Yahoo? Nope. It is Facebook. What? That's crazy talk! Apparently not. And not only is it tops in terms of numbers, according to Mashable, it is also tops in terms of quality. Pe...
Thanks Chris - well said.
Commented Feb 8, 2010 on A Few Pharma Companies Speak to FDA Social Media Docket at Eye on FDA
A Few Pharma Companies Speak to FDA Social Media Docket
On January 29th new documents appeared in the FDA's docket that has been devised to collect commentary after the November 12-13 Part 15 meeting on social media and the Internet and medical product marketing. Up to this point, both in the actual meeting and in docket submission, medical product ...
No thanks, I dont need a list. I was there. I counted 4 medical products companies providing commentary. None in the docket. The commentary did not address the span of questions posed by the FDA. That means that less than 5% of major medical products companies responded. What do I want? I thought it obvious.
Commented Jan 29, 2010 on Social Media and Medicine Paradox - Is There a Movement or Not? at Eye on FDA
Social Media and Medicine Paradox - Is There a Movement or Not?
I am in Europe, where I have been giving a talk on Social Media and Medicine, similar to one I gave last week in Canada. In fact, I've been giving talks on Social Media and Medicine all over. Certainly, it seems, people are extremely interested in this topic. And for good reason. Because...
Ah! Many thanks!
Commented Jan 6, 2010 on DDMAC Warning and NOV Letter Summary, Third and Fourth Quarters, Part 1 at Eye on FDA
DDMAC Warning and NOV Letter Summary, Third and Fourth Quarters, Part 1
It is always important to look back and see what FDA's DDMAC is producing in the way of objections to promotional materials and practices communicated by medical manufacturers. In Part 1 of the examination of the third and fourth quarter of 2009, we take stock of the quantitative aspect for the...
Thanks, nicely done! Thanks for sharing. And Happy New Year.
Commented Jan 4, 2010 on Getting Organized at Eye on FDA
Getting Organized
According to Ezine, New Year's resolutions began back in 153 B.C. when Janus - the mythical king - was placed at the head of the calendar - hence the name January. Because of his particular physical characteristic of having two faces, Janus could look both backward and forward and assess bot...
Yes, you are right and I meant to mention that. I plan on stepping outside a lot and working this during the breaks.
Commented Nov 5, 2009 on Covering FDA's Part 15 Meeting on Social Media and Medical Product Promotion at Eye on FDA
Covering FDA's Part 15 Meeting on Social Media and Medical Product Promotion
Anyone in the pharma biz, and particularly the communications biz, is aware that on November 12 and 13, the FDA is holding a Part 15 meeting to gather input regarding the regulation of promotional communications through social media. The meeting begins a slow and laborious process that will las...
Arnie - point well taken. I think I was perhaps too enthusiastically
conveying what I thought was the FDA point of view and wasn't clear on that.
M
On Wed, Sep 23, 2009 at 9:41 AM, wrote:
Commented Sep 23, 2009 on FDLI Conference Part 4 - The Final Day at Eye on FDA
FDLI Conference Part 4 - The Final Day
With the best of intentions, I set out to live blog from the FDLI Conference. While Day 1 did not afford me an electrical outlet or a dynamic laptop battery, the second day I successfully planted myself next to an electrical outlet. Then my cell phone rang and my morning was consumed by an eme...
As always Pierce, you may be right. But it is their job to do this, and it
is their job to do it effectively. I'm only asking them to do their job.
On Tue, Sep 22, 2009 at 11:00 AM, wrote:
Commented Sep 22, 2009 on FDLI Conference Part 3 - Wrap Up of Day 1 at Eye on FDA
FDLI Conference Part 3 - Wrap Up of Day 1
I had planned on live-blogging from the conference, but there was a paucity of electric outlets at the venue and my battery was exceptionally lazy. Following her speech, during question and answer, I asked Dr. Woodcock the question that was left on the table following her outline of FDA's direc...
You are right. They are different and I do think there should be standards
for pharma communications via Twitter and other digital communications. But
if they are both announcing an approval, I don't think they are different.
My point is - it is the message not the medium is insufficient - and I
think that our discussion proves that. DDMAC needs to get off the dime.
I'm glad you like the blog. I like your comments too and always respond
when I have the time, which lately has been spare! Best, Mark
On Wed, Sep 16, 2009 at 3:04 PM, wrote:
Commented Sep 16, 2009 on Irony of Ironies - FDA Opens Up a Pharma-Based Twitter Feed at Eye on FDA
Irony of Ironies - FDA Opens Up a Pharma-Based Twitter Feed
For some time, the pharmaceutical industry has been wondering around the social media space with a blindfold on. With no guidance, and no indication of any position whatsoever, FDAs DDMAC has let each medical products take their chances in the social media space, occasionally enunciating policy...
Oh Pierce, you and I are always star crossed. If the FDA says that a
product is approved, and the company says a product approved and it is the
same message, what is the difference? How can news about a company be
different from news from a company. News is news.
On Wed, Sep 16, 2009 at 12:39 PM, wrote:
Commented Sep 16, 2009 on Irony of Ironies - FDA Opens Up a Pharma-Based Twitter Feed at Eye on FDA
Irony of Ironies - FDA Opens Up a Pharma-Based Twitter Feed
For some time, the pharmaceutical industry has been wondering around the social media space with a blindfold on. With no guidance, and no indication of any position whatsoever, FDAs DDMAC has let each medical products take their chances in the social media space, occasionally enunciating policy...
Thank you so much for pointing it out. The last time I had checked in
August, it had not been posted, despite the fact that other comments made
subsequently had been. Appreciate the head's up.
On Tue, Sep 15, 2009 at 9:51 PM, wrote:
Commented Sep 16, 2009 on How Transparent is the FDA Transparency Blog? at Eye on FDA
How Transparent is the FDA Transparency Blog?
Last month, I wrote a posting called "When Transparency is Easy -Advisory Committee Transparency" suggesting that the transparency at FDA would be greatly enhanced if there were once again links from the rosters of advisory committee members to their CVs. Such links used to be common place, now...
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