Since July 2008 the US Food and Drug Administration (FDA) has been seeking volunteers to submit chemistry, manufacturing and controls (CMC) information for biologics in an expanded change protocol consistent with QbD.
Volunteers now have until September 30 2010 to submit written and electronic requests to participate. Investigational new drug (IND) applications and post approval supplements must be submitted by March 31 2011.
Furthermore, the pilot is being expanded from five to eight original applications for products reviewed by the Office of Biotechnology Products.
