“She was using government employees

These are drugs going into humans. It not like cooking a hot dog, you have to take into account every single part of the process and even minor changes in sourcing of materials, equipment or dosage form means you be spending a lot of time and money proving to the FDA and yourselves that everything is equivalent. While I didn’t work on this project beyond some small tasks, I was well in tune with the development.In my nearly 20 years of developing medical devices, this matches my experience with the FDA in the last 15 years.

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