|Filed Under:||Medical / Pharmaceutical|
|Posts on Regator:||317|
|Posts / Week:||1.4|
|Archived Since:||November 3, 2010|
It is that time of year when the temperatures can range by 30 degrees from morning until afternoon. The pollen counts are high and already sudden storms appear on the horizon to dump a lot of rain and then move … Continue reading ?
Where are we when it comes to the regulation of search and digital media by FDA? After issuing some guidance documents, we know a little more about FDA’s approach to digital and social media, but there are still many outstanding … Continue reading ?
A few weeks ago it snowed, this week the lawn mowers were revved up. The car is covered in pollen. The cherry trees in DC have peaked. The ranks of tourists have swollen. Taxes have all been done and filed … Continue reading ?
In the years past when the Office of Prescription Drug Promotion (OPDP) issued Warning Letters (WL) and Notice of Violation (NOV) letters with regularity, it was the custom here at Eye on FDA to review them on a quarterly basis. … Continue reading ?
March winds bring April showers. April showers bring May flowers. May flowers bring pilgrims. Ha. It is April – 2015 speeds at a breath-taking speed. The yard work continues to wait, but the daffodils do not and have arrived in … Continue reading ?
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 ?
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 ?
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 ?
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 ?
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 ?
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 ?
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 ?
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 ?
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 ?
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 ?
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 ?
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 ?
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 ?
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 ?
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 ?