Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products; Notice of Extension of Deadlines to Request Participation in Pilot Program and to Submit Applications; and Notice of Increase in the Number of Original Applications in Pilot Program

摘要

The Food and Drug Administration (FDA) is announcing an extension of the deadline for submitting requests to participate in a pilot program involving the submission of quality (chemistry, manufacturing, and controls (CMC)) information for biotechnology products in an Expanded Change Protocol consistent with the principles of quality-by-design and risk management in pharmaceutical manufacturing. Because the deadline for requests to participate in the pilot is being extended, FDA is also extending the application submission deadlines. FDA is also announcing an increase in the number of original applications being accepted into the pilot program.