On July 2, 2008, the Food and Drug Administration (FDA) announced that it is inviting pharmaceutical companies to volunteer to participate in a pilot program designed to facilitate agency review of quality-by-design, risk-based approaches for manufacturing biotechnology products. The pilot involves the submission of quality (e.g., chemistry, manufacturing, and controls) information for biotechnology products in an Expanded Change Protocol, focusing on products reviewed by FDA’s Office of Biotechnology Products (OBP) within the Center for Drug Evaluation and Research. The pilot is open to original submissions of and supplements to biologic license applications or new drug applications reviewed by OBP. Requests to participate in the pilot program must be submitted by September 30, 2009, and comments on the program can be submitted through 2008.