This course provides an overview and summary of the investigational product development process. The course includes information on the different phases of clinical research necessary to file an Investigational New Drug Application (IND) and a new Drug Application (NDA).  The course discussed the purpose of each phase, key differences between pharmaceutical and medical device development, and factors that contribute to the size and expense of clinical trials.

Topics include:
      ·          Stages of new product development
      ·          Trial phases
      ·          How the development of medical devices differs from drug products
      ·          FDA approval
      ·          What trials may be conducted after submission for approval

Linda Belmont at DIA