In this third, and final installment on new directions for FDA under the watch of a new Commissioner, we turn to the issue of opioids. When Dr. Robert Califf was being considered for confirmation as FDA Commissioner he faced a … Continue reading
In Part 1 of FDA New Directions, we looked at the issue of pricing. Today we’re looking at implementation of the 21st Century Cures Act (the Act). Prior to becoming the FDA Commissioner, Dr. Gottlieb was a strong supporter of … Continue reading
With a change in leadership at FDA there naturally a great deal of anticipation with regard to the potential for new direction for the agency and the impact it will have on the agency’s diverse stakeholders. That is especially true … Continue reading
“I am a cancer survivor, I was treated for cancer during my last tour at FDA, so I k now the importance of what American medicine does — and what the FDA does — for every one of us.” Scott … Continue reading
Thirty years ago, HIV advocates elevated the notion of patient involvement in the development of new medicines to entirely unprecedented levels by demanding input into multiple aspects of clinical development of HIV treatments. That included not only in the way … Continue reading
