|Filed Under:||Medical / Pharmaceutical|
|Posts on Regator:||360|
|Posts / Week:||1.6|
|Archived Since:||November 3, 2010|
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 ?
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 ?
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 ?
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...
The New Year has gotten off to a very chilly start here in Washington, D.C. But we have a new Congress that has been sworn in as the 114th. I have cleared the Eye on FDA tab on the blog … Continue reading ?
There are two types of letters issued by FDA’s Office of Prescription Drug Promotion (OPDP) related to its role in regulating the commercial speech of medical product manufacturers – Warning Letters (WLs) and Notice of Violation (NOV) letters. One can … Continue reading ?
Of course, it is entirely a subjective matter to pick out the most interesting stories of the year. When it comes to an agency that oversees the regulation of one-quarter of the U.S. economy spanning everything from medicines to cosmetics … Continue reading ?
The holidays have left little time for posting, but here is at least getting in the Weekly Roundup. Hopefully, however, with the respite that is to come, there will be time to build up some editorial content. In the meantime, … Continue reading ?
Christmas cards not addressed because they aren’t bought. Gifts aren’t wrapped because of the same reason. I am definitely naughty. FDA Expands Approval of Lilly’s Cyramza - The most common type of lung cancer, non-small cell lung cancer (NSCLC) saw … Continue reading ?
Time has been in short supply, but having survived Thanksgiving – guests, cooking and eating and gearing up for the gearing down of the calendar year (and the beginning of longer days) and it is time for a little breather. … Continue reading ?
We have just been through an election cycle and the 113th Congress is in lame duck session. We are about to move on to the new Congress in January 2015. Who did America elect and what is their position on … Continue reading ?
Last week I posted about the update to the database of pharma and social media use with respect to the increase in audience over last year. While FDA’s OPDP was so complacent in coming forth in guidelines, the number of … Continue reading ?
It is a lovely autumn in our nation’s capital – at least looking at the trees and the light. It is always remarkable how the light angles change and the sun will suddenly appear beneath clouds instead of over them … Continue readin...
As a highly regulated industry, the pharmaceutical sector was very slow to embrace social media and given the very slow and highly restrictive guidance put out by FDA on that topic, branded participation – particularly on Twitter – is going … Continue reading ?
Autumn is well upon us. Nature is showing us how diverse her color palette really is and it is always important to take some time and stop and enjoy it — sometimes hard to do when the demands of world … Continue reading ?
We are days away from the mid-term elections. Don’t worry, this isn’t another piece to read about how the Senate could hang in the balance for weeks; or how one party or another might retain or take control of any … Continue reading...
Missed last week and sorry about that and this week’s roundup is a day late. It has been a busy Fall and even yesterday was a travel day. I can barely keep up with how quickly the year is passing. … Continue reading ?
It is hard to believe it, but we have entered the final quarter of 2014. I thought it a good time to revisit the upcoming AdComm schedule for those AdComm meetings that affect drugs or devices. Prior postings that provided … Continue reading ?
Back from a brief vacay to discover that leaves are littering the yard and porch as if it were autumn and then realizing that it is, in fact, autumn. The year is going by so quickly and there is so … Continue reading ?
It is hard to believe that a service that limits your speech to 140 characters would emerge as an important media platform, but it has. News travels more quickly, is more granular in nature, can very specific to highly targeted … Continue reading ?