|Filed Under:||Medical / Pharmaceutical|
|Posts on Regator:||435|
|Posts / Week:||1.2|
|Archived Since:||November 3, 2010|
During a somewhat slow week given the holiday that coincides with the end of the second quarter, this is a good time to look back at press releases for the quarter and the year so far. A single press release … Continue reading ?
Thirty years ago, HIV advocates elevated the notion of patient involvement in the development of new medicines to entirely unprecedented levels by demanding input into multiple aspects of clinical development of HIV treatments. That included not only in the way … Continue reading ?
Over the past three decades, we have gone from Hillarycare to Obamacare to Trumpcare. The mere fact that healthcare is characterized by the names of public figures is testament to the extreme politicization of an important public policy issue. The … Continue reading ?
Thirty years ago today, the man seated at the left died of complications from AIDS. The man standing on the right is me. This photograph was taken six weeks before he died. We were just 31 years old. Last week, … Continue reading ?
To put it mildly, enforcement by the Office of Prescription Drug Promotion (OPDP) has been lagging. Warning and Untitled letters from this office numbered in the triple digits twenty years ago. In the past three years, it did not break … Continue reading ?
For the second time in as many years, we have been going through the ritual of getting a new FDA Commissioner appointed. The last one – Dr. Robert M Califf served from February 2016 until January of this year. Dr. … Continue reading...
Anyone who reads this blog knows that apparently I like to count things. Why? Well it provides the basis to confirm or refute general observations, and also can provide perspective that makes you stop and think and wonder. But if … Continue reading ?
It is a different era of enforcement. So far the first quarter of 2017 has not yielded a single regulatory action letter from the Office of Prescription Drug Promotion (OPDP). That said, in December of 2016 OPDP put out more … Continue reading ?
In his remarks to a joint session of Congress delivered this week, President Trump expressed the point of view that the “slow and burdensome approval process at the Food and Drug Administration keeps too many advances… from reaching people in … Continue reading ?
The number of new drugs approved by FDA last year fell – by many indicators. There were fewer new molecular entities approved and there were fewer press releases about approvals during the year compared to 2015. And consequently, there were … Continue reading ?
It was another year of low-level enforcement by the FDA Office of Prescription Drug Promotion (OPDP). In fact, if you added the number of letters issued over the past three years it would be one less than the number of … Continue reading ?
During the campaign, candidate Donald Trump made several statements referring to the fact that he would be cutting regulation in this country by 70-80 percent. Since the election, that sentiment has been repeatedly affirmed. Now in office, this week he … Continue reading ?
FDA ended the year quietly and began the new year in similar fashion. The holidays are of course a factor, but in all of October and November of 2016, there were only 3 releases issued for each month. Even in … Continue reading ?
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 ?