Upper School Intersession 2025

It takes an average of $1.3 billion and more than 10 years to bring a new medicine to the point of applying for FDA approval. After pursuing this long and often tortuous path, the prospects are risky, and the FDA faces a binary choice: Grant marketing authorization, or reject the application?

What does the drug development process entail, and why is it so long, expensive, and complex? What is FDA's role in protecting American consumers and the public? How are the concepts of "benefit" and "risk" used to provide a framework for these decisions?

In this interactive session, you will learn the basics of the drug development process, including the role of the FDA in deciding whether to allow access to new drugs. Students will work in groups to evaluate whether a new drug should be "approved", and, if so, under what conditions.