|Filed Under:||Medical / Pharmaceutical|
|Posts on Regator:||292|
|Posts / Week:||1.7|
|Archived Since:||November 3, 2010|
Last weekend was so warm I got to take my first bike ride and went around the Mall. It was delightful with temps in the 60?s. Early in the week, I was excited to find a blooming crocus where just … Continue reading ?
Keeping my eye on FDA, and being most interested in communications, AND having a penchant for looking at patterns through databases, I started categorizing FDA press releases to see what they talked about and in what way. I only started … Continue reading ?
The snow has melted and the ground is soggy. Looking at the ground there are daffodil tops poking out of the dirt and this morning on my dog walk, I spotted my first two crocus blooming purple. The volume of … Continue reading ?
In Part 1, we covered the need for good communications planning, in Part 2, a little bit about how to go about it and in Part 3, some thoughts about the day of your meeting. You have developed your narrative … Continue reading ?
Well, I am really tardy with this posting – the Weekly Roundup is not only late, it is real late. Sorry, it was not Valentine’s Day festivities, nor was it a result of the snow storms – some of which … Continue reading ?
Last week, after a talk I gave on the subject, I put up a posting Building a Case, AdComm Preparation, Part 1, where I talked about some of the reasons why communications is almost as important of a factor in … Continue reading ?
Hello. Eight years ago yesterday – February 9, 2006 – I began this blog with my first posting. Since then, I have published 1250 more postings. Though it seems like only yesterday, 2006 was a very different time: George W. … Continue reading ?
Well, it has been one long winter. I have the February blues and I am blaming that fact on my being a bit tardy with the Weekly Roundup here. While I love a good snow fall, the fact is that … Continue reading ?
Today I am giving a talk here in Washington about preparation for advisory committees. Over the years, I have had occasion to attend more meetings of FDA Advisory Committees than I care to think about, often with the purpose of … Continue reading ?
The Advisory Committee calendar put up by FDA is very useful, but lists the upcoming meetings chronologically by date and by their named committee. I thought it might be helpful every so often to provide an overview of upcoming AdComm … Continue reading ?
It will be groundhog day this coming week. I know I will be watching to see what is predicted because I, for one, am done with the cold nature of this surly winter. Dog walks have been painful. Cars everywhere … Continue reading ...
Many regular readers might remember last September when I was able to share the news that a friend had named a new born calf after me – Marky! Well, Marky is growing up and here she is – pictured behind … Continue reading ?
So last week there was a lot of interest and commentary on the issuance of a draft guidance by FDA that provided some insight into how the agency is regulating promotional speech and social media platforms. It seemed like a … Continue reading ?
Two full weeks back in the saddle and I’m ready for a three day weekend. I’m late today with the Weekly Roundup, and there isn’t a lot of news to digest, but here are a few things that came out … Continue reading ?
Don’t judge a book by its cover – or in this case, title. In November 2009, FDA held a two-day public meeting on the Promotion of FDA-Regulated Medical Products Using the Internet and Social Media to collect input for the … Continue reading ?
As we all emerge from the first full work-week of the new year, there is among many a sa strong shared sense that the last 5 days have actually been more like 5 weeks. And even though it seemed like … Continue reading ?
I usually wait a little bit longer after the end of the quarter to write up a summary of letters issued by the Office of Prescription Drug Promotion (OPDP) because there can sometimes be a healthy lag time between the … Continue reading ?
What? A Weekly Roundup after such a short quiet week? And a week when there was a snow storm to boot? Even these sheepdogs can’t find the sheep to round up! Well it may have seemed like a quiet, … Continue reading ?
Happy New Year! It is natural for each of us to look back on the year and see where we did well and where we stumbled and also to assess how the past year might shape the one to come. … Continue reading ?
Yes, I did it. Cards addressed and sent. Gifts purchased, wrapped and sent. The snow in my snow globe descends quietly and peacefully conveying my own inner serenity…. And here is a little of what happened this week, as 2013 … Continue reading ?