Federal Register Notice: FDA is seeking pharmaceutical firm volunteers to participate in a pilot program on the submission of quality (chemistry, manufacturing, and controls) information for biotechnology products in an Expanded Change Protocol, consistent with the principles of quality-by-design and risk management in pharmaceutical manufacturing. The program’s purpose is to gain more information on and facilitate agency review of quality-by-design, risk-based approaches for manufacturing biotechnology products. This pilot will focus on products reviewed by CDER’s Office of Biotechnology Products and is intended to help FDA in developing guidance for industry on quality-by-design and risk management in pharmaceutical manufacturing. The pilot is open to original submissions of and supplements to BLAs or NDAs reviewed by OBP. To view this notice, click here.