Pilot Program on Quality Information for Biotechnology Products
The 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) information for biotechnology products in an Expanded Change Protocol consistent with the principles of quality-by-design and risk management in pharmaceutical manufacturing. FDA also is extending the application submission deadlines and increasing the number of applications being accepted into the pilot program. Requests to participate in the pilot program are due September 30, 2010, and investigational new drug applications and postapproval supplements are due March 31, 2011.
