Getting FDA and other regulators into the process early as a guide is important, as is maintaining the dialogue. When Murdeshwar talks about seeking guidance, he doesn't mean asking FDA how to do something. It's more about explaining planned approaches and protocols and asking if they are acceptable.

"I send them protocols, they read through our protocols, they come back with questions. We sit down and have discussions with the questions they have. And then we do the work," Murdeshwar says. "People who don't have this direction end up copying what someone else did. When you copy what someone else did, you lose your way. You're trying to answer questions they might not even be interested in."

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[Image courtesy of Pixabay]