Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products; Notice of Pilot Program

Streszczenie

The Food and Drug Administration (FDA) is seeking volunteers from pharmaceutical companies to participate in a pilot program involving 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 purpose of the pilot program 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 FDA's Office of Biotechnology Products (OBP), in the Office of Pharmaceutical Science (OPS), Center for Drug Evaluation and Research (CDER). This pilot program will assist 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 biologic license applications (BLA) or new drug applications (NDA) reviewed by OBP.