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Having passed the mid-year point, it is always an interesting exercise to take stock of where we stand with respect to the approval of new medicines. Overall, when considering the volume of activity, things would seem to be looking up – at least in terms of the volume of activity. First let’s look at the …
For the second time this month and the third time this year, FDA’s OPDP has posted notice that it has taken an enforcement action. Last week, a Warning Letter was posted regarding a sales aid. This week it action came in the form of an Untitled Letter (NOV) sent to a company regarding a paid …
In what has been a long period of relative low activity, FDA’s OPDP has taken the opportunity to remind us that low enforcement does not mean no enforcement when it comes to promotional speech by pharmaceutical companies. This past June FDA posted an Untitled Letter, the first regulatory action letter in a year, reported on …
FDA’s OPDP Issues Second Regulatory Action Letter of 2023 Read More »
Every six months, we do a look-back to see what has changed in the way that FDA is communicating. One might not think there is much difference over time, but there is. For example, the air has pretty much gone out of the COVID balloon. And there is more to tell. How many? First of …
What They Said – Reviewing the First 6-Months of FDA Communications Read More »
For those who are regular followers of what FDA’s Office of Prescription Drug Promotion (OPDP) is up to, there was a surprise this week when the office posted the first regulatory action letter – in this case an Untitled Letter (a/k/a Notice of Violation (NOV) Letter) in over a year. The particulars of the letter …
It Finally Happened – FDA’s OPDP Issues First Letter of 2023 Read More »
In today’s Federal Register, the agency has announced that the Office of Prescription Drug Promotion (OPDP) is adding a new study effort to its research portfolio. The category of that body of research that is currently underway includes a range of topics, including an assessment of terms and phrases commonly used in prescription drug promotion, …
FDA Announces New Study on Endorsements and DTC Television Ads Read More »
FDA Commissioner Califf has voiced a desire to limit voting in Advisory Committee Meetings Recently there have been a spate of reports carried in trade media that Commissioner Califf would prefer to limit the voting mechanism customarily included as a key part of FDA Advisory Committee meetings. Traditionally, committee votes can be taken on a …
Thumbs Up, Thumbs Down – Minimizing Votes in AdComms Read More »
In January we took a look at FDA Advisory Committees (AdComms) – FDA AdComms – When the Going Gets Tough – noting, among other things that there had not only been fewer meetings but also that it appeared that the outcomes were increasingly negative. Just to recap, for the entire year of 2022 there were …
Big Decisions – Reviewing FDA Advisory Committee Outcomes Since 2020 Read More »
Two announcements occurred this week, both of note and connected only by the fact that they are emblematic of the slow metamorphosis from a COVID emergency world to a post-COVID emergency one. Emergency Ends – First, the Biden Administration announced that it would be allowing the Public Health Emergency (PHE) declaration to lapse this coming …
Emerging from Emergency – Two COVID-Related Developments This Week Read More »
Each year Eye on FDA provides a look-back to see what the agency was talking about and what has changed over time. This year is a telling one and FDA may be changing the nature of the way they are communicating with the public. Moreover, this year is marked by the fact that the agency …
What They Said – Looking Back at FDA Press Releases During 2022 Read More »
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