Newsletter - May 25, 2017
Two Unique Approvals in a Week; FDA’s Baby Steps, Industry’s Giant Leap
This week FDA announced with great fanfare two approval decisions using unique regulatory approaches that would seem to indicate a shift in its thinking about data supporting such decisions. But a careful observation shows that these are baby steps, at best. In the case of Kalydeco, a cystic fibrosis drug... Read More
Janet Woodcock Pulled a Frances Kelsey and Everyone is Mad
In FDA’s long and illustrious history, there are very few watershed moments that can be attributed to one person at the Agency. FDA historians consider the decision by Frances Kelsey to not approve thalidomide in 1960, despite extensive pressure to do so, as one of pivotal moments in its history that defined how it regulates drugs. Read More
Two Unique Approvals in a Week; FDA’s Baby Steps, Industry’s Giant Leap
This week FDA announced with great fanfare two approval decisions using unique regulatory approaches that would seem to indicate a shift in its thinking about data supporting such decisions. But a careful observation shows that these are baby steps, at best. In the case of Kalydeco, a cystic fibrosis drug... Read More
Janet Woodcock Pulled a Frances Kelsey and Everyone is Mad
In FDA’s long and illustrious history, there are very few watershed moments that can be attributed to one person at the Agency. FDA historians consider the decision by Frances Kelsey to not approve thalidomide in 1960, despite extensive pressure to do so, as one of pivotal moments in its history that defined how it regulates drugs. Read More
