Comprehensive Drug Development

Optimize Opportunities and Avoid Potential Pitfalls


A strategic plan begins with a firm foundation - ask yourself these questions before you begin - and if you are unsure about the answer, call Camargo today.

  • What is the difference between 505(b)(1) first-in-man and 505(b)(2) bridging studies?
  • Are stability studies or clinical studies the limiting factor on FDA submissions for 505(b)(2)?