FDA gives another year for biologics CMC pilot applications
This article was originally published in The Gold Sheet
Executive Summary
FDA Sept. 17 pushed back the Sept. 30 deadline by a year for requests to participate in its chemistry, manufacturing and controls submission pilot for large-molecule products. FDA also expanded the slots for original applications to eight from five for the expanded change protocol pilot, patterned after a 2005 CMC pilot for applying new design space and risk-based concepts to small-molecule drugs