CBER coming to a plant near you
This article was originally published in The Gray Sheet
Executive Summary
Biologics manufacturers have until Oct. 25 to submit a request to participate in CBER's regulatory site visit training program. The Center for Biologics Evaluation & Research wants to provide its "regulatory review staff, compliance staff and other relevant staff an opportunity to visit biologics facilities [in order to gain] first-hand experience." Groups of five or fewer CBER staff members will visit participating companies to "observe operations of biologics manufacturing, packaging, pathology/toxicology lab testing and regulatory affairs operations"...