Problem 1: Please find 5 countries and identify their regulatory agency which is equivalent to the US FDA. Please list the name and a summary of each agency, by comparing and contrasting each of their regulatory pathways for drugs and devices.
Problem 2: For one country from question 1, describe 2 challenges and resolutions associated with conducting a clinical trial in that country.
Problem 3: Explain the purpose of a clinical trial registration and submission of trial results from perspective of global trial (both domestic and foreign trial sites).
Problem 4: What is the current FDA position for including international clinical data for both drugs and devices?