|Filed Under:||Medical / Pharmaceutical|
|Posts on Regator:||422|
|Posts / Week:||1.3|
|Archived Since:||November 3, 2010|
It has been a rather extraordinary month for watchers of the Office of Prescription Drug Promotion (OPDP) in that while the office has issued very little enforcement during the bulk of the year, December has been making up for it. … Continue reading ?
It has been a while since there has been a Weekly Roundup posting, primarily because FDA has been fairly quiet of late. In fact, during October the agency issued only 3 press releases and the same for November. Certainly lots … Continue reading ?
The Office of Prescription Drug Promotion (OPDP) has been particularly low-key this year when it comes to visible enforcement actions expressed through the issuance of Warning or Untitled letters. Up until this week, the office had issued only 5 letters … Continue reading ?
As the year ends, it is time to look back at what has occurred during the year and what hasn’t. Let’s begin with approvals. I noted recently in a Tweet that during the months of October and November, FDA had … Continue reading ?
In Part 1 about change facing FDA, we looked at the 21st Century Cures Act and some of the change that would be in store for FDA. But in this post-election cycle, there is more than pending legislation that could … Continue reading ...
One of the often stated priorities for lame-duck Congress has been voting on the 21st Century Cures Act. In a press release from Saturday, November 26 from the House Energy and Commerce Committee, the House is set to vote on … Continue reading ?
There is a good deal of commentary about what happened at the nationally in this year’s election cycle. But a good deal happened at the state level as well – things that will impact healthcare and may influence how other … Continue reading ?
This week FDA published a notice in the Federal Register seeking comment on the proposed collection of information regarding research entitled “Character-Space-Limited Online Prescription Drug Communications“. The notice states that the objective of the research is to test whether a … Continue reading ?
We are almost through it! Just a few more days. In the meantime, the more enjoyable aspects of autumn, chilly nights, fires in the fireplace, and brilliant leaves are all upon us. Soon the end of year holidays will be … Continue reading ?
It has been way too long since a Weekly Roundup and way too long since a regular posting. The autumn has turned out to be an exceptionally busy time so apologies on both fronts. But today I’m carving out a … Continue reading ?
The shifting of gears is happening before our eyes. Already leaves are falling and the morning alarm goes off in the final moments of night time darkness rather than the first rays of morning sunshine. The trees are signalling that … Continue reading ?
In recent years FDA has undertaken several means to facilitate the consideration of new drug applications by creating various mechanisms for expedited review for either new drugs or new indications for existing drugs. Prior to 2012, there had long been … Continue reading ?
Kids are back in school. The air is kinder, gentler and less harsh than the last heated days of summer, though summer tries to hang on some days, it is ebbing into Autumn. Halloween candy has already appeared in stores. … Continue reading ?
The end of summer. This is less like a Weekly Roundup than a Monthly Roundup. Like everyone else, I have taken August with a grain of salt. It feels a little lonely writing blog postings when you know that readers … Continue reading...
I always enjoy doing a periodic check in on what states are doing when it comes to healthcare issues. Utilizing the excellent data base resources at the National Conference of State Legislatures, one can examine numerous categories of legislation that … Continue reading ?
When an FDA Advisory Committee meets and deliberates whether or not the new drug application put before the agency should or should not be approved, they gather together and deliberate in a public forum often for hours. Prior to the … Continue reading ?
The lawn is a lovely shade of brown. What can one say after that? The hot, humid days always evoke for me very strong childhood memories when the days were long and the season far too short and time was … Continue reading ?
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 ?