Blog & Resources Camargo Blog October 30th, 2007

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?

*Add this blog to your RSS feeds!

Get Our Expertise Working for You

To learn how you can benefit from our regulatory and strategic development expertise, view our solutions or contact us.

Camargo Pharmaceutical Services provides comprehensive drug development solutions, specializing in customized programs including the 505(b)(2) pathway.

9825 Kenwood Road
Suite 203
Cincinnati OH, 45242
Durham Office
800 Taylor Street
Suite 101
Durham NC, 27701
Montreal Office
507 Place d'Armes
Suite 1101
Montreal, QC H2Y 2W8, Canada
Phone 513.561.3329
Toll Free 888.451.5708
Subscribe for our Latest Insights