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Newsletter - May 25, 2017
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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

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