This program provides an overview of how the U.S. Food and Drug Administration fits into the overall regulatory oversight of the biotechnology and drug industry. Our discussion of key sources of FDA law includes an overview of regulated products, general requirements for marketing including clinical studies, and special programs such as orphan drugs to consider, and will highlight the intersection of FDA regulation with biologics litigation under the BPCIA, emphasizing the need for coordinated strategy between FDA regulatory and patent litigation teams to effectively serve biopharma clients.