FDA Opens Pilot Program for Biotech

Rockville, MD (July 10)-The US Food and Drug Administration is seeking volunteers from the pharmaceutical industry to participate in a pilot program involving the submission of quality information for biotechnology products. Focused on chemistry, manufacturing, and controls information, the Expanded Change Protocol will be consistent with the principles of quality by design (QbD) and risk management.

The purpose of the pilot program is to gain more information about QbD and to facilitate agency review of QbD and risk-based approaches for manufacturing biotechnology products, according to a July 2 notice. The pilot program will focus on those products reviewed by FDA’s Office of Biotechnology Products, which operates in the Office of Pharmaceutical Science at the Center for Drug Evaluation and Research. The agency hopes the program will assist in the development of guidance for industry on QbD and risk management.

The program is open to original submissions of and supplements to biologic license applications and new drug applications, according to the notice. Requests to participate in the pilot program are due Sept. 30, 2009. Comments on the pilot program are due Dec. 31, 2008. All correspondence can be sent to: Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852, or submitted online at www.regulations.gov.