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505(b)(2) – Part 1: The overall process

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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