|Filed Under:||Medical / Pharmaceutical|
|Posts on Regator:||442|
|Posts / Week:||1.2|
|Archived Since:||November 3, 2010|
One season winds down, another offers hints of a beginning. I am afraid that both the regular Weekly Roundup as well as regular postings have lately been interrupted by some domestic issues that came up for me as well as … Continue reading ?
As hurricane season made itself felt this week, summer seems over in the east. Kids are back to school and this weekend summer whites and linens have their final appearance before next Memorial Day. Meanwhile it was a very busy … Continue reading ?
A departure from the usual FDA fare. The blog is meant to cover FDA issues, but also various aspects of communications. This is a story about media training, sort of. Jay Thomas died yesterday. He was 69 years old. He … Continue reading ?
I’ve decided to bring back the Weekly Roundup. I have missed it and especially now with the prospect of a good deal of change in healthcare in general and FDA in particular, much more is happening than I would ever … Continue readin...
In Part 1 of FDA New Directions, we looked at the issue of pricing. Today we’re looking at implementation of the 21st Century Cures Act (the Act). Prior to becoming the FDA Commissioner, Dr. Gottlieb was a strong supporter of … Continue reading ?
With a change in leadership at FDA there naturally a great deal of anticipation with regard to the potential for new direction for the agency and the impact it will have on the agency’s diverse stakeholders. That is especially true … Continue reading ?
“I am a cancer survivor, I was treated for cancer during my last tour at FDA, so I k now the importance of what American medicine does — and what the FDA does — for every one of us.” Scott … Continue reading ?
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 ?