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 research into a vaccine is aggressively underway, we also see serious … Continue reading
Vaccines for COVID-19 are the focus of the moment – politically and scientifically speaking. On the political front, there has not only been jockeying to try to squeeze the square peg of a vaccine development timeline into a round hole … Continue reading
Since last week’s posting regarding FDA credibility being on the line, there has been a swirl of activity and commentary around the evaluation of vaccine research for COVID-19 that would seem to have exacerbated the problem. For context, last week … Continue reading
In normal times, when there is no pandemic threatening our lives and livelihoods, it is essential for FDA to maintain the traditional “gold standard” in relation to the decision-making process for the approval of new treatments. That standard is even … Continue reading
Each year, midway through it all, I take a look back to see what FDA has been talking about and compare it to the year before to see how things may have changed. I’m a little late at getting to … Continue reading
