The first step in the US on your path towards eventual approval is a pre-IND Meeting, which will facilitate communication with the FDA and provide the advantage of early feedback on your development program. This first meeting establishes the tone of your Agency relationship, and as one of the desired outcomes, you want the Agency to gain respect for your company and your science.
This first meeting establishes the tone of your Agency relationship, and as one of the desired outcomes, you want the Agency to gain respect for your company and your science.