The use of biopharmaceutical products has increased greatly over the past twenty years and is expected to continue to increase in volume and importance in years to come. Like many other manufacturing operations, there has been a substantial increase in the globalization of biopharmaceutical production within the last five to ten years. The FDA, the Government Accountability Office, and Congress are well aware of the challenges and tradeoffs involved when industries globalize, and in response the FDA has adjusted its inspection policies and practices. Funds from this grant will support a multidisciplinary team of researchers based at MIT's Center for Biomedical Innovation and led by Georgetown University Professor Jeffrey Macher, in their work to study how globalization has changed regulatory practice surrounding the production and distribution of biopharmaceuticals.