Our process for developing a drug product to be submitted to the US FDA under the 505(b)(2) process has been validated during many meetings with FDA. I want to share important aspects of this process with the community.
This is the first post of several parts. I will use the following flow diagram as our road map. Do you need all of the steps in the process? Perhaps not, but how do you know? Stay tuned*, read through all of the parts and you’ll know how to find out:
- what studies do we have to do?
- what will the studies cost?
- when can I submit?
- what are the chances my drug can make money?
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