In announcing the next phase or version 2.0 to the Innovation Pathway program introduced in February last year, CDRH Director Jeffrey Shuren said that the program is going to bring about a new way of doing business at the FDA. The new regime will be one where safety and innovation are complementary rather than at odds with each other. Through Innovation Pathway 2.0, the goal is to get entrepreneurs in companies or academia who are designing the next innovative, breakthrough product to collaborate with the FDA early on. That will help iron out regulatory uncertainty that tends to gobble up time when a novel product is actually submitted for a de novo or a premarket approval.
I like the sound of this, but I’m not going to hold my breath… We’ll see what happens.