I don’t usually publish the scheduling of an AdComm with a blog posting. But this one merits one. With fewer than the usual minimum of fifteen days’ notice, FDA has scheduled an FDA Advisory Committee meeting of the Cardiovascular and … Continue reading
The impacts of the COVID-19 pandemic bring change shifts the status quo on a daily basis with both breadth and depth. Everything we as individuals and as a society would normally do is undergoing change. FDA regulatory oversight is one … Continue reading
It is time to look at the forest rather than the trees. It has been a regular custom to occasionally look back and see what FDA has been saying, and how frequently the agency has been saying it and what … Continue reading
Happy New Year! It is 2020 – the year of clear vision. Let’s look back for a bit as we plunge forward. FDA is a giant agency where a lot happens. Narrowing down the actions of significance is therefore a … Continue reading
One of the many things notable during the tenure of Dr. Scott Gottlieb as FDA Commissioner was the change in communications – a change marked not just by style but substance. In fact, in a March posting here, it was … Continue reading
