Day: October 10, 2019

Over the last seven years, FDA has initiated numerous programs to increase patient perspective in the development of new drugs that they may need. Starting with the Patient-Focused Drug Development (PFDD) meetings that started in 2012, FDA has increased the weight of patient perspective in regulatory decisions. However, sponsors need instructions on how to interact … Read more

Several expedited programs for market approval created in the last decade has led to products approved in much shorter time and with seemingly lesser burden of proof leading to critics accusing FDA of lowering its standards of approval and allowing riskier drugs to be used on patients. A blog by FDA leaders of the centers … Read more