AdComms – Is FDA Getting Less Advice?
As more drugs are being approved, is FDA getting less advice than in the past? FDA maintains a vast network of outside advisors to provide input and
As more drugs are being approved, is FDA getting less advice than in the past? FDA maintains a vast network of outside advisors to provide input and
Well. They said a lot. A lot more than ever, as one might expect. This past year, FDA issued a whopping 420 press releases, more so by far than any
Each year in January, it is relevant to look back on the activities of FDA during the course of the previous year and look at how it was the same or
First of all, we are having a bit of a crisis with our crisis. As we appear to be moving into yet another wave of COVID-19 infections, and as
In normal times, when there is no pandemic threatening our lives and livelihoods, it is essential for FDA to maintain the traditional “gold
As the year began, no one really thought that within a few months, the systems upon which we rely on for just about everything would be so severely
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
Photo: Getty The Food and Drug Administration recently updated its guidance on a temporary food labeling policy that has been causing widespread
In response to written questions submitted last month regarding the potential for delays, FDA had stated that “CDER remains fully capable to
With the COVID-19 impact making itself apparent on a daily basis as the numbers climb and organizations respond, the effects on the pharma and
Empty FDA Advisory Committee Meeting Room Earlier this month I published a blog posting that raised questions related to the potential for disruption
Much attention has been paid to the impact of the COVID-19 pandemic on the supply chain for medicines we rely on, but there has been less focus on
Atrium at FDA 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
There is a policy interest in driving the biosimilar market. Among other reasons, increasing the number of generic drugs and biosimilars on the
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