|Filed Under:||Medical / Pharmaceutical|
|Posts on Regator:||405|
|Posts / Week:||1.4|
|Archived Since:||November 3, 2010|
Well, it is really hot. Really really hot. And I am moving kind of slow, as one should probably do in the summer. I didn’t even get to the Weekly Roundup last week, which means that some of what I … Continue reading ?
What do FDA press releases for the year say about the rate of new approvals for 2016? Periodically I take a look at what FDA has said – and a little bit conversely at what it hasn’t. In April, I … Continue reading ?
Perhaps it is a throwback to childhood, but summer always seems to go by faster than other seasons. And this summer is no exception. Sunflowers are blooming, daisies are beaming, lawn mowers are mowing. It seems everywhere you look, summer … Continue reading ?
I recall a time when the head of a regulatory department of a pharmaceutical company told me that the company would never, ever, ever under any circumstances be involved in social media. By my count, today that company has twenty-one … Continue reading ?
We are enjoying more respite from heat here in the mid-Atlantic. Certainly a difficult week that brought reflection and sadness for many. And so we’ll get right down to some of the things that happened FDA-related that were noteworthy: Tragedy … Continue reading ?
We are finally getting some weather that could be described as delightful. I hope that you are too. The grass is green, a breeze blows and there is lots of birdsong in the air. For the first time in years, … Continue reading ?
Weekly Roundups have been in absentia for the past few weeks. Forgive me – it has not been for lack of wanting to get the job done, just time. May began with a serious bout of the flu. While it … Continue reading ?
Back when the Office of Prescription Drug Promotion (OPDP) issued regulatory action letters on a regular basis (either Warning Letters or Untitled Letters) regarding what the agency saw as infractions in the course of promotional speech, I would post a … Continue reading ?
This week media carried reports that Twitter was going to making a shift in policy regarding space. Until now, you have been limited to 140 characters in your tweeting which included space for your – albeit tiny – URL and/or … Continue reading ?
Back in February in a post entitled “From HIV to Zika – The Role of Communications“, I listed several of the hallmark characteristics involving the communications environment and emerging pathogens, drawing not only on recent observations with respect to Ebola, … Continue reading ?
Goodbye April. It was nice knowing you. There were a lot of noteworthy developments this week and I would like to write about them all, but as usual, will pick only a few from the bunch. FDA Issues Complete Response … Continue readi...
If you have Periscope on your phone, you may find yourself doing something and all of a sudden, hear a little whistle that is the sound cue to let you know that someone you follow has gone live. I set … Continue reading ?
A few weeks ago it was snow, now it is pollen – laden everywhere. Dogs, cars, outdoor seating, all covered in a fine yellow haze. Or is that me? I have had such a busy week that the result has … Continue reading ?
It seems safe to say we are officially done with snow. Winter is finally at our backs. In the rear view mirror. Yes, we have shifted gears into that very, very short time of the spring – at least here … Continue reading ?
Election cycle aside, it is going to be a rough summer. As things stand, this will likely become the summer of Zika as the country faces a growing potential for dealing with transmission inside the U.S. and abroad. As the … Continue reading ?
I put the herbs into the garden on a warm and balmy day last weekend only to fall victim to freeze warnings a day later so brought them in the house. Warms up. Put them back outside and then another … Continue reading ?
There are going to be times when FDA has less to say than at other times. In fact, there have actually been times where the agency has gone weeks without issuing a press release about anything. This quarter was not … Continue readin...
The year is now officially one-fourth done. We have a long, hot summer to slog through that will no doubt be followed by a tumultuous autumn election cycle, so it is perhaps best now to take time and enjoy the … Continue reading ?
One area of FDA activity that I like to track is in relation to advisory committees which I think provide us with something of a surrogate marker for the pace at which FDA is considering and approving new drugs. To … Continue readin...
Well the first quarter of 2016 has sure blown by. We had the earliest Equinox since the 19th Century. Someone flipped a switch and everything started blooming at once. The cherry blossoms got well underway this week. And here is … Continue reading ?