Blog Profile / Eye on FDA


URL :http://www.eyeonfda.com/
Filed Under:Medical / Pharmaceutical
Posts on Regator:375
Posts / Week:1.6
Archived Since:November 3, 2010

Blog Post Archive

Weekly Roundup 3.27.15

Another busy week – hence a day late with the Weekly Roundup. This week, I cleared one of the flower beds of the dead stems from winter and filled three lawn and leaf bags with leaves and stems.  They took … Continue reading ?

Is Bigger Safer? OPDP Enforcement Patterns and Company Size

Eye on FDA has frequently carried overviews and summaries of enforcement by the Office of Prescription Drug Promotion (OPDP) through the issuance of Warning and Untitled Letters (regulatory action letters). These letters, along with guidance documents that are occasionally issued … Continue reading ?

Weekly Roundup 3.20.15

There really is more to Eye on FDA than the Weekly Roundup, but this month you wouldn’t know it. Busy schedule combined with a few health issues have resulted in a diminished output, hopefully to be put right now that … Continue reading ?

Weekly Roundup 3.13.15

On the road this week left little time for posting, though some interesting things happened. And meanwhile, back in Washington, D.C., the last vestiges of snow have departed and on my dog walk, I spotted blooming purple crocuses which was … Continue reading ?

Weekly Roundup 3.6.15

I found myself dreaming about picking herbs from my herb garden and thinking of expanding my efforts there this year to include new items. I imagined flowers blooming out on back deck. And these whimsical thoughts all occurred while I … Continue reading ?

Communications in a Biosimilar Age Almost Upon Us

When policy changes, communications must support the change by informing the stakeholders how it impacts them and the decisions they will have to make. When it comes to biosimilars, now is such a time. The question is – who does … Continue reading ?

Weekly Roundup 2.27.15

Another round of snow this week, perhaps the last gasp of winter? I can’t say there is any hint of Spring in the air in these parts, but sure hope there is where you are. In any event, I am … Continue reading ?

Legislative Proposals in the 114th Congress

Every so often, EyeonFDA has an update for you on legislation that is proposed in the Congress that would impact the medical product marketplace if passed.  The new Congress has just two months old and while the last Congress was … Continue reading ?

Weekly Roundup 2.20.15

Friiiiiiggggggiiiiiiiddddd.  I realize anyone who doesn’t live in the Northeast can’t really complain, but winter finally woke up in the capital of our nation. Last week I took a picture of green daffodil sprouts coming up from the grounds of … Continue reading ?

The Language of Risk – FDA’s Evolution of Thought

How does the average patient assess the risk of a medical product when deciding whether or not to seek it out? This month, FDA released a new draft guidance document entitled “Brief Summary and Adequate Directions for Use: Disclosing Risk … Continue reading ?

Weekly Roundup 2.13.15

Happy Friday the 13th and the day before Valentine’s Day. It is cold.  There is fierce wind. Boston is due more snow. As if there aren’t enough reasons to dislike February…. For me the week flew by and I hope … Continue reading ?

Eye on FDA’s 9th Birthday

It is hard to believe, but today – February 9, 2015 – I have passed the ninth marker of Eye on FDA. It seems like only a short time ago that I was reading a friend’s excellent and humorous blog … Continue reading ?

Goodbye Dr. Hamburg

In lieu of the Weekly Roundup this week, the report is dedicated to a sole development – the announcement by Dr. Margaret Hamburg of her departure from FDA after six years as FDA Commissioner. She leaves behind a number of … Continue reading ?

How We Communicate Matters – Comparing Communications Vehicles and Regulatory Enforcement

One of the benefits of tracking the regulatory actions of FDA through the Office of Prescription Drug Promotion (OPDP) is that it allows you to take the information and view it from different perspectives to look for interesting lessons and … Continue reading ?

FDA’s Novel Year of Novel Drug Approvals – 2014

Of course it is more than a roll of the dice. A lot of work and effort goes into medical treatment applications for approval and into evaluating them for consideration. As was widely discussed in FDA-watching circles, the agency approved … Continue reading ?

Weekly Roundup 1.30.15

2015 is already 1/12th over with. Frightening. A winter storm came and went from the East Coast. Here in Washington, we are still waiting for our first serious snowfall and it is not yet on the horizon. We are done taking … Continue reading ?

Weekly Roundup 1.23.15

It seems 2015 is moving even faster than 2014 as we prepare for the last week of January even though it feels as if the holidays were only last week. It has been that time of year for reflection, looking … Continue reading ?

Review of Warning and Untitled Letters for 2014

Earlier this month, I had posted about the steep decline in FDA’s OPDP enforcement rates as the number of Warning and Untitled letters for 2014 hit a new low of only ten for the year. In the posting, I had … Continue reading ?

Weekly Roundup 1.16.15

It is a three-day weekend! Granted we just had the holidays, but they are very filled with exhausting activity – decorating, receiving guests, being a guest, wrapping.  We need some recover time and in the spirit of the weekend, to … Continue reading ?

FDA Press Releases – 2014 What They Said and How They Said It

Last year, Eye on FDA had a posting that examined the press releases of the previous year, relying on a new tracking system I had implemented for that purpose.  This being the second year of the database, we can not … Continue readi...

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