In some recent postings, it has been noted that the FDA Commissioner has made liberal use of the vehicle of “Commissioner Statements”. Last month, there were 9 – on average 2 a week. Then suddenly this month, the entire first … Continue reading
Last week Kaiser Health News (KHN) released a database called “Pre$cription for Power” that tracked pharmaceutical company donations made to patient advocacy groups, with an extensive accompanying article. The database is an important collection of information and serves to enhance transparency … Continue reading
For those of superstition, it is the first of two Friday the 13ths for this year. For the rest of us, we are assessing our bad luck with regard to the fact that if you live in the mid-Atlantic it … Continue reading
It goes without saying that enforcement by FDA’s Office of Prescription Drug Promotion (OPDP) as identified through regulatory action letters (warning or untitled) over the past few years is a mere shadow of its former self. Enforcement was once robust, … Continue reading
This has been a rather extraordinary year from an FDA perspective. Last year there were record approvals and a number of firsts. Advances in oncology have been eye opening to say the least. And on a policy front, there has … Continue reading
